(36 days)
No
The document describes a surgical laser system and its intended uses, focusing on the physical components and surgical applications. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, decision support, or automated control beyond basic system operation.
Yes
The device is described as a "Surgical Laser" intended for various surgical procedures, including ablation, vaporization, excision, incision, and coagulation of soft tissue to treat numerous medical conditions across multiple specialties. These actions directly address or modify health conditions, fitting the definition of a therapeutic device.
No
Explanation: The device is described as a "Surgical Laser" intended for "surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue." Its "intended use" and "indications for use" consistently describe therapeutic interventions (treating, removing, ablating, etc.), not diagnostic processes (detecting, identifying, screening).
No
The device description explicitly lists hardware components such as a laser console, fiber port, footswitch/handswitch, and fiber optic delivery devices. While it mentions "operating software," the device is clearly a physical laser system with associated hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser used for procedures involving the ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties. These are all procedures performed on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device description details a laser console, delivery systems (fiber optic cables, handpieces), and accessories like sterilization trays. This aligns with a surgical device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition based on sample analysis
- Reagents or test kits
The device is a surgical tool used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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)
- 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.
- limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:
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 enxdonasal 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, varices, 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethral, ureteral, external genitalia, penile, ureter, ureteropelvic junction, L4-5 and L5-S1 lumbar discs of the vertebral spine, various joints of the body (excluding the spine), knee, shoulder, sigmoid colon, cholecystectomy, mastectomy, hepatectomy, pancreatectomy, splenectomy, hemorrhoidectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, appendectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, lipoma, pelvic, oral, nasal, glossal, pharyngeal, laryngeal, uterus, intra-uterine, intra-abdominal, cervix, esophageal, gastrointestinal, tracheobronchial tree, skin, subcutaneous tissue, foot, brain, spinal cord, cranial nerves, peripheral nerves, pituitary glands, eye.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K980685, K933318, K932981, K923575, K914991, K914136, K910037, K902990, K895518
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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;
1
- 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. ●
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.
8
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
9
| 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:
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)
*** 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
10
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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11
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.
- limited to open, percutaneous and arthroscopic vaporization of the L4-5 and 1
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
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Division of General Restorative Devices
Division of General Restorative 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
12
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
| 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 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) ***
13
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) ***
14
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.
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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