The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

Ho:YAG urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgery; and general surgery; and
Nd:YAG urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, endonasal surgery/ENT surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in gynecology, neurosurgery, ophthalmology, and lumbar discectomy as follows:
Ho:YAG - Urology

Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH)
Ho:YAG - Urology - Continued
Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
bladder;
urethral and ureteral tumors;
condylomas;
lesions of external genitalia;
urethral and penile hemangioma;
urethral strictures;
bladder neck obstructions.
Urinary Lithotripsy including:
endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic junction;
treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Nd:YAG - Urology
Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including:
removal of superficial bladder tumors;
removal of invasive bladder carcinoma;
removal of benign or malignant lesions of the external genitalia, including condylomas;
treatment of urethral strictures;
treatment of vascularities of the bladder wall;
prostatectomy.
Ho:YAG - Arthroscopic Surgery / Arthroscopy
Arthroscopy (ablation, excision and coagulation of soft tissue) in various joints of the body, excluding the spine, including:
meniscectomy;
plica removal;
ligament and tendon release;
contouring and sculpting of articular surfaces;
debridement of inflamed synovial tissue.
Discectomy including:
percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine;
open and arthroscopic spine procedures.
Nd:YAG - Orthopaedic Surgery
Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
Knee
capsulectomy in the knee;
chondroplasty in the knee;
plica removal in the knee;
lateral ligament release in the knee;
meniscectomy in the knee;
synovectomy in the knee;
osteoarthritic lesion removal in the knee;
Shoulder
coracoacromial release in the shoulder;
debridement of scar tissue in the shoulder;
adhesive capsule release in the shoulder;
labral tear repair in the shoulder;
synovectomy in the shoulder.
Discectomy:
limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:
unilateral leg pain greater than back pain;
paresthetic discomfort in a specific dermatomal distribution;
positive straight leg raising test and/or positive bowstring sign;
possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration;
no improvement after at least 6 weeks of conservative therapy;
positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.
Ho:YAG - General Surgery
Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
cholecystectomy;
lysis of adhesions;
appendectomy;
removal of benign and malignant lesions;
biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon.
Nd:YAG - General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
cholecystectomy;
mastectomy;
hepatectomy;
pancreatectomy;
splenectomy;
hemorrhoidectomy;
thyroidectomy;
parathyroidectomy;
herniorrhaphy;
tonsillectomy;
appendectomy;
lymphadenectomy;
partial nephrectomy;
pilonidal cystectomy;
resection of lipoma;
pelvic adhesiolysis;
removal of lesions;
removal of polyps;
removal of tumors;
tumor biopsy;
debridement of decubitus ulcers.
Ho:YAG - Endonasal Surgery
Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
partial turbinectomy;
ethmoidectomy;
polypectomy;
maxillary antrostomy;
frontal sinusotomy;
sphenoidotomy.
Nd: YAG - Ear, Nose and Throat (ENT) Surgery
Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
tonsillectomy;
adenoidectomy.
Ho:YAG - Gynecological Surgery
Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).
Nd:YAG - Gynecological Surgery
Gynecological surgery limited to:
treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;
soft tissue excisional procedures such as excisional conization of the cervix.
Nd:YAG - Gastroenterologic Surgery
Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;
gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.
Nd:YAG - Thoracic and Pulmonary Surgery
Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
laryngeal lesions;
airway obstructions including carcinoma;
polyps and granulomas;
palliation of obstructing carcinomas of the tracheobronchial tree.
Nd:YAG - Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
lesions of skin and subcutaneous tissue;
telangiectasia;
port wine lesions;
spider veins;
hemangiomas;
plantar warts;
periungual and subungual warts;
removal of tattoos;
debridement of decubitus ulcer;
treatment of keloids.
Nd:YAG - Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
matrixectomy;
plantar warts;
neuromas;
periungual and subungual warts;
radical nail excision.
Nd:YAG - Neurosurgery
Neurosurgery limited to:
hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.
Nd:YAG - Ophthalmology
Ophthalmology limited to:
post-vitrectomy photocoagulation.

Device Description

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components:

a laser console;
control and display panel;
a fiber port for delivery systems;
system microprocessor control electronics;
a covered footswitch or handswitch;
operating software;
an optional remote control unit;
a variety of fiber optic delivery devices with accessories (described below).

The Coherent Delivery Devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components:

laser connector;
handpiece;
probe tube;
probe tip;
fiber optic cable.

The Coherent Accessories (sterilization trays) are comprised of the following functional components:

tray lid and tray bottom;
latches;
instrument supports.

AI/ML Overview

This appears to be a 510(k) summary for a medical device (Modified Coherent VersaPulse Select Surgical Lasers and Delivery Devices with Accessories). 510(k) submissions, particularly from 1999, typically do not include detailed acceptance criteria and standalone study results in the manner requested for AI/software devices.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the standard for 510(k) clearance. This means demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials that would test specific performance metrics against an acceptance criterion in a rigorous statistical study.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) are not explicitly present or applicable in this type of submission.

However, I can extract information related to the device description, intended use, and the basis for its clearance:

Here's an analysis based on the provided text, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with specific thresholds. In a 510(k) for a device like this, the "acceptance criteria" are generally that the device is "substantially equivalent" to predicate devices in terms of safety and effectiveness for its intended use. This is demonstrated by comparing design features, functional features, and indications for use.
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific laser efficacy rates) are reported. The "performance" is implicitly considered equivalent to the predicate devices.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (Implied from Substantial Equivalence)
Shared Indications for Use with Predicate Devices	All indications for use are identical to predicate devices.
Similar Design Features to Predicate Devices	Design described as similar to predicate devices.
Similar Functional Features to Predicate Devices	Functional features described as similar to predicate devices.
Equivalent Safety and Effectiveness to Predicate Devices	Device is found to be safe and effective when used as indicated, equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/not provided. This submission is for device clearance based on substantial equivalence, not a new clinical trial with a defined "test set" of patient data for performance evaluation. The "testing" referred to would be engineering verification and validation against specifications, not clinical performance against a ground truth.
Data Provenance: Not applicable/not provided. Since no clinical "test set" data is used to prove performance in the context of AI, there's no data provenance to report. The basis for clearance relies on the established safety and effectiveness of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable/not provided. No "ground truth" establishment in the context of an AI performance evaluation is described.
Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No. This is a 1999 510(k) for a surgical laser, not an AI-assisted diagnostic device. The concept of MRMC studies for AI assistance would not apply here.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: No. This is not an AI algorithm. Its "performance" is its ability to deliver laser energy as designed and indicated, which is demonstrated through engineering testing and comparison to predicate devices, not through standalone algorithm performance metrics.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. For a surgical laser, the "ground truth" of its functionality is its ability to perform the specified actions (ablation, vaporization, incision, etc.) safely and effectively, which is assessed through engineering testing and clinical experience with similar devices, rather than a "ground truth" derived from patient data in the typical sense of an AI study.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary of the Study and Why it Meets Acceptance Criteria (Based on 510(k) document):

The "study" presented in this 510(k) is a substantial equivalence determination, not a clinical trial with specific performance acceptance criteria.

The Device: Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories.
The "Study" (Rationale for Substantial Equivalence): The submission argues that the modified device is substantially equivalent to several legally marketed predicate devices (listed under Section III). This equivalence is based on:
- Shared Indications for Use: The modified device has the same indications for use as the predicate devices across many medical specialties (urology, arthroscopy, general surgery, ENT, etc.).
- Similar Design Features: The device components (laser console, control panel, fiber port, footswitch/handswitch, software, remote control unit, fiber optic delivery devices, sterilization trays) are similar in design to predicate devices.
- Similar Functional Features: The device performs similar functions to the predicate devices, i.e., ablation, vaporization, excision, incision, and coagulation of soft tissue using Ho:YAG and Nd:YAG laser energy.
Meeting Acceptance Criteria: The implicit "acceptance criteria" for a 510(k) is that the device is "as safe and effective" as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The submission concludes that this acceptance criterion is met by demonstrating the similarities described above, and referencing "Safety and effectiveness information" that was provided to the FDA (though details of this information are not in the public summary). The FDA's letter of clearance (K990947) confirms that they too found the device substantially equivalent for the stated indications.

In essence, the "study" is a comparative analysis against existing, cleared devices, rather than a de novo performance study against pre-defined quantitative metrics.

Summary

{0}------------------------------------------------

K 990947

4/24/97

Attachment 14 510(k) Summary Statement for the Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

March 19, 1999

General Information I.

Coherent Medical Group Submitter: 2400 Condensa Street Santa Clara, California, U. S. A. 95051-0901 Michelle P. Deeton Contact Person:

Summary Preparation Date:

II. Names
Device Names:

Select Single Modified Coherent VersaPulse Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and compatible fiber optic laser delivery devices with accessories (sterilization trays)

Primary Classification Name: Laser Powered Surgical Instrument (and Accessories)

III. Predicate Devices

Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K980685, K933318);
Coherent VersaPulse Single Wavelength (Ho:YAG) and Coherent Ho:YAG Surgical Lasers (K932981, K923575, K914991, K914136, K910037, K902990, K895518);
Coherent SlimLine Single Lumen Aspiration Needle Kit - Sterilization Tray-(K960413);
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (K974789); .
TTI Medical Accu-Beam Fiber Optic Handpiece (K952006). .

IV. Product Description

. a laser console;
control and display panel;

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a fiber port for delivery systems; .
system microprocessor control electronics; ●
a covered footswitch or handswitch; ●
operating software; ●
an optional remote control unit; ●
a variety of fiber optic delivery devices with accessories (described below). .

laser connector; ●
handpiece;
probe tube;
probe tip;
fiber optic cable.

The Coherent Accessories (sterilization trays) are comprised of the following functional components:

tray lid and tray bottom;
latches; ●
instrument supports. ●

Indications for Use . V.

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and their delivery accessories) are intended for use in surgical procedures involving open, laproscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

Ho:YAG - urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgical; and general surgery; and
Nd:YAG - urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, endonasal surgery/ENT surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in gynecology, neurosurgery, ophthalmology, and lumbar discectomy as follows:

{2}------------------------------------------------

Ho:YAG - Urology

· Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH).

Ho:YAG - Urology - Continued

Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
- bladder;
- urethral and ureteral tumors;
- condylomas;
- lesions of external genitalia;
- urethral and penile hemangioma;
- urethral strictures;
- bladder neck obstructions.
· Urinary Lithotripsy including:
- endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic junction;
- treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Nd:YAG - Urology

· Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including:
- removal of superficial bladder tumors;
- removal of invasive bladder carcinoma;
- removal of benign or malignant lesions of the external genitalia, including condylomas;
- treatment of urethral strictures;
- treatment of vascularities of the bladder wall;
- prostatectomy.

Ho:YAG - Arthroscopic Surgery / Arthroscopy

· Arthroscopy (ablation, excision and coagulation of soft tissue) in various joints of the body, excluding the spine, including:
- meniscectomy;
- plica removal;
- ligament and tendon release;
- contouring and sculpting of articular surfaces;
- debridement of inflamed synovial tissue.
· Discectomy including:
- percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine;
- open and arthroscopic spine procedures.

Nd:YAG - Orthopaedic Surgery

· Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
Knee
capsulectomy in the knee;

{3}------------------------------------------------

chondroplasty in the knee;
plica removal in the knee;
lateral ligament release in the knee;
meniscectomy in the knee;
synovectomy in the knee;
osteoarthritic lesion removal in the knee;

Shoulder

coracoacromial release in the shoulder;
debridement of scar tissue in the shoulder;
adhesive capsule release in the shoulder;
labral tear repair in the shoulder;
synovectomy in the shoulder.
· Discectomy (limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with):
- unilateral leg pain greater than back pain;
- paresthetic discomfort in a specific dermatomal distribution;
- positive straight leg raising test and/or positive bowstring sign;
- possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration;
- no improvement after at least 6 weeks of conservative therapy;
- positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.

Ho:YAG - General Surgery

· Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
- cholecystectomy;
- lysis of adhesions;
- appendectomy;
- removal of benign and malignant lesions;
- biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon.

Nd:YAG - General Surgery

· Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- cholecystectomy;
- mastectomy;
- hepatectomy;
- pancreatectomy;
- splenectomy;
- hemorrhoidectomy;
- thyroidectomy;
- parathyroidectomy;
- herniorrhaphy;
- tonsillectomy;
- appendectomy;
- lymphadenectomy;
- partial nephrectomy;

{4}------------------------------------------------

pilonidal cystectomy;
resection of lipoma;
pelvic adhesiolysis;
removal of lesions;
removal of polyps;
removal of tumors;
tumor biopsy;
debridement of decubitus ulcers.

Ho:YAG - Endonasal Surgery

Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
- partial turbinectomy;
- ethmoidectomy;
- polypectomy;
- maxillary antrostomy;
- frontal sinusotomy;
- sphenoidotomy.

Nd:YAG - Ear, Nose and Throat (ENT) Surgery

· Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
- tonsillectomy;
- adenoidectomy.

Ho:YAG - Gynecological Surgery

· Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Nd:YAG - Gynecological Surgery

· Gynecological surgery limited to:
- treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
- intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
- intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;
- soft tissue excisional procedures such as excisional conization of the cervix.

Nd:YAG - Gastroenterologic Surgery

· Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;
- gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, - Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
- gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.

{5}------------------------------------------------

Nd:YAG - Thoracic and Pulmonary Surgery

· Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
- laryngeal lesions;
- airway obstructions including carcinoma;
- polyps and granulomas;
- palliation of obstructing carcinomas of the tracheobronchial tree.

Nd:YAG - Dermatology and Plastic Surgery

· Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- lesions of skin and subcutaneous tissue;
- telangiectasia;
- port wine lesions;
- spider veins;
- hemangiomas;
- plantar warts;
- periungual and subungual warts;
- removal of tattoos;
- debridement of decubitus ulcer;
- treatment of keloids.

Nd:YAG - Podiatry

· Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- matrixectomy;
- plantar warts;
- neuromas;
- periungual and subungual warts;
- radical nail excision.

Nd:YAG - Neurosurgery

· Neurosurgery limited to:
- hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.

Nd:YAG - Ophthalmology

· Ophthalmology limited to:
- post-vitrectomy photocoagulation.

VI. Rationale for Substantial Equivalence

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the Coherent VersaPulse Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K980685, K933318) and the Coherent VersaPulse Single Wavelength (Ho:YAG) and Coherent Ho:YAG Surgical Lasers (K932981, K923575, K914991, K914136, K910037, K902990, K895518). The

{6}------------------------------------------------

operating platform in the Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers is also substantially equivalent to the operating platform in the Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (K974789). The Coherent Delivery Devices are substantially equivalent to the previously cleared Coherent ( K933318, K923575, K914991, K910037, K902990 and K895518) and TTI Medical (K952006) delivery devices. The Coherent Accessories (sterilization trays) are substantially equivalent to the sterilization tray in the Coherent SlimLine Single Lumen Aspiration Needle Kit (K960413).

Safety and Effectiveness Information VII.

Safety and effectiveness information was provided to demonstrate that the Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories are safe and effective, when indicated for use for general and specific applications in the medical specialties of urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological; and general surgery; for Ho:YAG and urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy for Nd:YAG.

VIII. Conclusion

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories were found to be substantially equivalent to similar currently marketed and predicate surgical lasers, delivery devices and accessories.

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories share the same indications for use, similar design features, and similar functional features as the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1999

Ms. Michelle P. Deeton Senior Regulatory Affairs Associate Coherent Medical Group 2400 Condensa Street Santa Clara, California 95051-0901

K990947 Re:

Trade Name: Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery Devices with Accessories

Regulatory Class: II Product Code: GEX Dated: March 19, 1999 Received: March 22, 1999

Dear Ms. Deeton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Ms. Michelle P. Deeton

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin McWilliams, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K990947
Device Name :	Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and
	Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery
	Devices with Accessories

Indications For Use:

Ho:YAG urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; ● gynecological surgery; and general surgery; and
Nd:YAG urology; general surgery; gastroenterology; thoracic and pulmonary . surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

Ho:YAG - Urology

· Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH)
*** Indications For Use Continued on Next Page (6 pages total) ***

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990947

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

510(k) Modified VersaPulse Select and Delivery Devices with Accessories

Attachment 4 - Page 1

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510(k) Number (if known):

Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and Device Name :__ Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery

Devices with Accessories
Indications For Use Continued:

Ho:YAG - Urology - Continued

Open and endoscopic urological surgery (ablation, vaporization, incision, excision . and coagulation of soft tissue) including treatment of:
- bladder; t
urethral and ureteral tumors;
condylomas; -
lesions of external genitalia; -
urethral and penile hemangioma; 1
urethral strictures; -
bladder neck obstructions. -
Urinary Lithotripsy including:
- endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic ﮯ junction;
- treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Nd:YAG - Urology

Urological surgery (ablation, vaporization, incision, excision and coagulation of soft ● tissue) including:
- removal of superficial bladder tumors; -
- removal of invasive bladder carcinoma; t
- removal of benign or malignant lesions of the external genitalia, including condylomas;
- treatment of urethral strictures; t
- treatment of vascularities of the bladder wall; -
- prostatectomy. 1

Ho:YAG - Arthroscopic Surgery/Arthroscopy

Arthroscopy (ablation, excision and coagulation of soft tissue) in yarious joints of the body, excluding the spine, including:
- meniscectomy; -
- plica removal;
- ligament and tendon release;
  - contouring and sculpting of articular surfaced wisson of General Restora
- 510(k) Number _ debridement of inflamed synovial tissue.

Prescription Use (Per 21 CFR 801.109)

●

* Indications For Use Continued on Next Page (page 2 of 6) *

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510(k) Number (if known):

Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and Device Name :

Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery
- Devices with Accessories

Indications For Use Continued:

Discectomy including: .
- percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine;
- open and arthroscopic spine procedures.

Nd:YAG - Orthopaedic Surgery

Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
Knee

●

capsulectomy in the knee; -
chondroplasty in the knee; ﺳ
plica removal in the knee; -
lateral ligament release in the knee; -
meniscectomy in the knee; -
synovectomy in the knee; -
osteoarthritic lesion removal in the knee; .

Shoulder

coracoacromial release in the shoulder; -
debridement of scar tissue in the shoulder; -
adhesive capsule release in the shoulder; -
labral tear repair in the shoulder; -
synovectomy in the shoulder. -
Discectomy:
- limited to open, percutaneous and arthroscopic vaporization of the L4-5 and 1
  - L5-S1 lumbar discs of the vertebral spine in patients with:
  - unilateral leg pain greater than back pain; .
  - paresthetic discomfort in a specific dermatomal distribution; .
  - . positive straight leg raising test and/or positive bowstring sign;
  - possible neurologic finding including wasting, weakness, sensory ● alteration and reflex alteration;
  - no improvement after at least 6 weeks of conservative therapy; ●
  - positive CT or MRI showing a subligamentous herniation at the location ● consistent with clinical findings.

Ho:YAG - General Surgery

Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
- cholecystectomy; -
- lysis of adhesions; -
  - *** Indications For Use Continued on Next Page (page 3 of 6) ***

DC
(Division Sign-Off)
Division of General Restorative Devices

Division of General Restorative 510(k) Number

Prescription Use

(Per 21 CFR 801.109)

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name :	Modified Coherent VersaPulse Select Single Wavelength Ho:YAG andDual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery
---------------	--------------------------------------------------------------------------------------------------------------------------------

Devices with Accessories
Indications For Use Continued:
appendectomy; ﮯ
removal of benign and malignant lesions; ﮯ
biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon. -

Nd:YAG - General Surgery

Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including:
- cholecystectomy; -
- mastectomy; -
- hepatectomy; -
- pancreatectomy; -
- splenectomy; -
- hemorrhoidectomy;
- thyroidectomy;
- parathyroidectomy;
- herniorrhaphy;
- tonsillectomy;
- appendectomy;
- lymphadenectomy;
- partial nephrectomy;
- pilonidal cystectomy;
- resection of lipoma;
- pelvic adhesiolysis;
- removal of lesions;
- removal of polyps;
- removal of tumors;
- tumor biopsy;
- debridement of decubitus ulcers. "

Ho:YAG - Endonasal Surgery

Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of ● soft tissue and cartilage) including:
- partial turbinectomy;
- ethmoidectomy; ﺖ
- polypectomy; -
- maxillary antrostomy; -
- frontal sinusotomy; -
- sphenoidotomy. =

Doello

(Division Sign-Off) Division of General Restorative Devices 9091 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

*** Indications For Use Continued on Next Page (page 4 of 6) ***

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510(k) Number (if known):

Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and Device Name :

Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery
- Devices with Accessories

Indications For Use Continued:

Nd: YAG - Ear, Nose and Throat (ENT) Surgery

Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of . soft tissue) including:
- lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
- tonsillectomy; -
- adenoidectomy. t

Ho:YAG - Gynecological Surgery

Open and laparoscopic gynecological surgery (ablation, vaporization, incision, ● excision, and coagulation of soft tissue).
Nd:YAG - Gynecological Surgery
Gynecological surgery limited to:
- treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
- intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
- intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;
- soft tissue excisional procedures such as excisional conization of the cervix.

Nd:YAG - Gastroenterologic Surgery

Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;
- gastrointestinal hemostasis including, varicies, esophagitis, esophageal . ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, and gastric erosions;
- gastrointestinal tissue ablation of benign and malignap(t neoplasm, hemorrhoids and polyps.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of General Restorative Device 510(k) Number

*** Indications For Use Continued on Next Page (page 5 of 6) ***

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510(k) Number (if known):

Modified Coherent VersaPulse Select Single Wavelength Ho:YAG and Device Name :_________________________________________________________________________________________________________________________________________________________________

Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers and Delivery
Devices with Accessories

Indications For Use Continued:

Nd:YAG - Thoracic and Pulmonary Surgery

Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and . coagulation of soft tissue) including treatment of:
- laryngeal lesions; -
- airway obstructions including carcinoma; ﺘ
- polyps and granulomas; -
- palliation of obstructing carcinomas of the tracheobronchial tree. =

Nd:YAG - Dermatology and Plastic Surgery

Dermatology and plastic surgery (ablation, vaporization, incision, excision, and . coagulation of soft tissue) including:
- lesions of skin and subcutaneous tissue; -
- telangiectasia; -
- port wine lesions; -
- spider veins; -
- hemangiomas; -
- plantar warts;
- periungual and subungual warts;
- removal of tattoos;
- debridement of decubitus ulcer;
- treatment of keloids. -

Nd:YAG - Podiatry

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) . including:
- matrixectomy; -
- plantar warts; -
- neuromas;
- periungual and subungual warts; =
- ﺖ radical nail excision.

Division Sign-Off)
of general Restorative Devices.

n. sun ber .

Nd:YAG - Neurosurgery

Neurosurgery limited to:
- hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.

Nd:YAG - Ophthalmology

Ophthalmology limited to:
- post-vitrectomy photocoagulation. l ***(page 6 of 6) ***

Prescription Use (Per 21 CFR 801.109)

510(k) Modified VersaPulse Select and Delivery Devices with Accessories

Attachment 4 - Page 6

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

General Information I.

III. Predicate Devices

IV. Product Description

Indications for Use . V.

Ho:YAG - Urology - Continued

Nd:YAG - Urology

Ho:YAG - Arthroscopic Surgery / Arthroscopy

Nd:YAG - Orthopaedic Surgery

Shoulder

Ho:YAG - General Surgery

Nd:YAG - General Surgery

Ho:YAG - Endonasal Surgery

Nd:YAG - Ear, Nose and Throat (ENT) Surgery

Ho:YAG - Gynecological Surgery

Nd:YAG - Gynecological Surgery

Nd:YAG - Gastroenterologic Surgery

Nd:YAG - Thoracic and Pulmonary Surgery

Nd:YAG - Dermatology and Plastic Surgery

Nd:YAG - Podiatry

Nd:YAG - Neurosurgery

Nd:YAG - Ophthalmology

VI. Rationale for Substantial Equivalence

Safety and Effectiveness Information VII.

VIII. Conclusion

Page 2 – Ms. Michelle P. Deeton

Ho:YAG - Urology - Continued

Nd:YAG - Urology

Ho:YAG - Arthroscopic Surgery/Arthroscopy

*** Indications For Use Continued on Next Page (page 2 of 6) ***

Nd:YAG - Orthopaedic Surgery

Shoulder

Ho:YAG - General Surgery

Nd:YAG - General Surgery

Ho:YAG - Endonasal Surgery

Nd: YAG - Ear, Nose and Throat (ENT) Surgery

Nd:YAG - Gastroenterologic Surgery

Nd:YAG - Podiatry

Nd:YAG - Neurosurgery

Nd:YAG - Ophthalmology

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

* Indications For Use Continued on Next Page (page 2 of 6) *