Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), COLIS, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization
Gastroenterological/Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, telangiectasias of the Osler-Weber-Rendu disease
General Surgery of soft tissue, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, hemiorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilodidal cyst removal and repair, debridement of statis ulcer, biopsy
Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, lesions of the external genitalia, bladder, urethral and ureteral tumors, condylomas, urethral and penile hemangioma, bladder neck obstructions, holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)
Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, fragmentation of kidney calculi, treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, debridement of the degenerative knee, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g., turbinectorny), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrostomy, frontal sinusotomy, sphenoidotomy
Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: foraminoplasty; Percutaneous Cervical Disc Decompression/Discectorny in soft tissue, in patients with: uncomplicated ruptured or herniated discs, neck pain with radiation down the arm, symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes, MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms, positive electromyography and/or nerve conduction studies, no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication); Percutaneous Thoracic Disc Decompression/Discectorny in soft tissue, in patients with: uncomplicated ruptured or herniated discs, thoracic and intercostal intractable pain, paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myclography, MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms, no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstital applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.

Device Description

The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.

AI/ML Overview

This document is a 510(k) premarket notification for the Trimedyne Holmium Laser System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based solely on the text provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report any specific acceptance criteria or performance metrics for the Trimedyne Holmium Laser System in relation to clinical or non-clinical studies. Instead, it states that:

"No non-clinical data were submitted in this Premarket Notification."
"No clinical tests were submitted in this Premarket Notification."

The basis for this 510(k) clearance is "substantial equivalence" to a predicate device, not fulfillment of specific performance criteria demonstrated through new testing.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable. No new clinical or non-clinical data/tests were submitted.
Data provenance: Not applicable. No new clinical or non-clinical data/tests were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new clinical or non-clinical data/tests were submitted, and therefore no ground truth was established by experts for such tests.

4. Adjudication method for the test set:

Not applicable. No new clinical or non-clinical data/tests were submitted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical laser system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical laser system, not an algorithm.

7. The type of ground truth used:

Not applicable. No new clinical or non-clinical data/tests were submitted for which ground truth would be established. The document relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not applicable. This document is for a medical device (laser system), not a machine learning or AI algorithm that would require a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, this document is not for an AI/ML algorithm.

Conclusion from the Document:

The Trimedyne Holmium Laser System received clearance based on substantial equivalence to an already legally marketed predicate device (also referred to as "Trimedyne Holmium Laser System"). This means the manufacturer demonstrated that the new device has the same intended use and technological characteristics as the previously cleared device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. As such, the submission did not include any new non-clinical or clinical data/tests to prove performance against specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Trimedyne" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Above the word "Trimedyne" is the text "k04 1660 1/2" in a handwritten font. Below the word "Trimedyne" is a graphic of three arrows stacked on top of each other.

SEP - 8 2004

Trimedyne® Holmium Laser System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter Information:	Trimedyne, Inc.15091 Bake ParkwayIrvine, CA 92618949-951-3800
Contact Person:	Glenn YeikPresident and COO
Summary Date:	20 August 2004

11. Device Name

Proprietary: Trimedyne Holmium Laser System, including:

OmniPulse™ Holmium Laser System (Model 1210) ●
OmniPulse MAX™ Holmium Laser System (Model 1210-VHP) .
OmniPulse Jr. TM Holmium Laser System (Model 1230-30) .
Model 1500-A Holmium Laser System .

Holmium: Yttrium Aluminum Garnet (Holmium: YAG) Laser Common:

Classification: Laser-Powered Instrument

!!!. Predicate Device

Trimedyne Holmium Laser System

IV. Device Description

V. Intended Use

The Trimedyne Holmium:YAG Laser System is indicated for superficial incision. excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in multispecialty applications.

When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, these laser systems may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.

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2/2

Technological Characteristics VI.

The laser system is a Holmium:YAG laser that emits light at a wavelength of 2.1 µm (near infrared) and a pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.

VII. Nonclinical Data

No non-clinical data were submitted in this Premarket Notification.

VIII. Clinical Data

No clinical tests were submitted in this Premarket Notification.

IX. Conclusion

The Trimedyne Holmium:YAG Laser System is substantially equivalent to the predicate device described in this Premarket Notification. Therefore, upon clearance of this submission, the Trimedyne Holmium: YAG Laser System will be marketed with the proposed modified/clarified indications.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

Trimedyne, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K041660 Trade/Device Name: Trimedyne Holmium Laser System, including: OmniPulse™ Holmium Laser System (Model 1210) OmniPulse MAX™ Holmium Laser System (Model 1210-VHP) OmniPulse Jr.TM Holmium Laser System (Model 1230-30) Model 1500-A Holmium Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be act noce a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally promated predicated with 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), please if you desire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milkman

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

Enclosure

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Indications for Use

K041660 510(k) Number:

Device Name: Trimedyne Holmium Laser System, including:

OmniPulse™ Holmium Laser System, Model 1210 .
OmniPulse MAX™ Holmium Laser System, Model 1210-VHP .
OmniPulse Jr.™ Holmium Laser System, Model 1230-30 .
Model 1500-A Holmium Laser System .

Indications for Use:

Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in l . therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including:
- scars .
- tattoo removal ﮩ
- vascular lesions (including port wine stains, ◆ hemangioma, telangiectasia [facial, leg], and rosacea)
- COLIS
- papillomas
basal cell carcinomas
- lesions of skin and subcutaneous tissue
- plantar warts
- periungual and subungual warts
- debridement of decubitus ulcer
- skin tag vaporization

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

ice of Device Eyaluation (ODE) Concurrence of CDRH, C

Mark A. Milleson

Division of General, Restorative, and Neurological Devices

510/k) Nu

K041660

Page 1 of 4

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Indications - continued

2. Gastroenterological/Gastrointestinal Surgery, including:

cholecystectomy +
lysis of adhesions �
appendectomy +
biopsy +
pylorostenotomy +
benign and malignant lesions ◆
rectal polyps of sigmoid colon ◆
gall bladder calculi �
biliary/bile duct calculi
benign and malignant neoplasm
polyps .
colitis +
ulcers
angiodysplasia
hemorrhoids
varices
esophagitis esophageal ulcer
Mallory-Weiss tear
gastric ulcer
duodenal ulcer
non-bleeding ulcer
gastric erosions
colorectal cancer
gastritis
bleeding tumors
pancreatitis
vascular malformations
telangiectasias
telangiectasias of the Osler-Weber-Rendu disease

3. General Surgery of soft tissue, including:

skin incision +
tissue dissection �
excision of external tumors and lesions +
complete or partial resection of internal organs +
tumors and lesions .
tissue ablation
mastectomy
hepatectomy
pancreatectomy
splenectomy
thyroidectomy
parathyroidectomy
hemiorrhaphy
tonsillectomy
lymphadenectomy
partial nephrectomy
pilonidal cystectomy
resection of lipoma
pelvic adhesiolysis
debridement of decubitus ulcer
hemorrhoids
pilodidal cyst removal and repair
debridement of statis ulcer
biopsy

4. Genitourinary Surgery/Urology, including:

superficial urinary bladder tumors
invasive bladder carcinoma
urethral strictures
lesions of the external genitalia
bladder
urethral and ureteral tumors
condylomas
urethral and penile hemangioma
bladder neck obstructions
holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)
N Millican

Restorative

K041660

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

Indications - continued

1. Gynecological Surgery during open and endoscopic procedures, including:
- condyloma acuminata

Lithotripsy and Percutaneous Urinary Lithotripsy, including: 6.

fragmentation of urinary calculi �
fragmentation of urethral calculi
fragmentation of kidney calculi
treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, 7. including:
- knee meniscectomy .
- knee synovectomy ◆
- chondromalacia and tears
- loose body debridement +
- lateral retinacular release .
- debridement of the degenerative knee
- plica removal
ligament and tendon release
contouring and sculpting of articular surfaces
debridement of inflamed synovial tissue .
capsulectomy in the knee .
chondroplasty in the knee
chondromalacia ablation
1. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:
- endosinus surgery �
- functional endoscopic sinus surgery +
- turbinate procedures (e.g., turbinectorny) .
- dacryocystorhinostomy (DCR)
- ethmoidectomy
polypectomy
. maxillary antrostomy
frontal sinusotomy
sphenoidotomy

Mark N. Wilkerson

510(k) Number

10(k) Number.

{7}------------------------------------------------

Indications - continued

Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: ರು. Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following:
- Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: .
  - foraminoplasty -
- Percutaneous Cervical Disc Decompression/Discectorny in soft tissue, in patients with:
  - uncomplicated ruptured or herniated discs -
  - neck pain with radiation down the arm .
  - symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes
  - MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
  - positive electromyography and/or nerve conduction studies -
  - no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
- Percutaneous Thoracic Disc Decompression/Discectorny in soft tissue, in patients with:
  - uncomplicated ruptured or herniated discs ー
  - thoracic and intercostal intractable pain -
  - paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myclography -
  - MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
  - no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

Mark N. Mulkerson

al. Fortorative. ological Devices

510(k) Number K041660

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.