(8 days)
The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.
The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
The provided document K053457 describes a 510(k) premarket notification for the VAPORMAX™ II Side Firing Fiber. It explicitly states that no nonclinical data and no clinical tests were submitted. Instead, the device's substantial equivalence was established by comparing its technological characteristics to a predicate device. Therefore, a study demonstrating the device meets acceptance criteria as typically understood in a clinical or performance study context was not performed or submitted.
Here's a breakdown based on your requested information, highlighting what is not applicable due to the nature of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific performance criteria tied to a clinical or non-clinical study were provided for this submission. The submission relies on substantial equivalence to predicate devices.) | Not Applicable (No specific performance metrics from a study were reported.) |
| Intended use: Incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers. | The VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, as concluded from substantial equivalence to predicate devices. |
| Mechanical properties (e.g., ability to withstand up to 100 watts of laser power). | The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX predicate and can therefore be used with up to 100 watts of laser power. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not applicable. No test set was used for a performance study.
- Data Provenance: Not applicable. No clinical or non-clinical study data were provided.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Not applicable. No test set was used, and therefore no ground truth was established by experts in the context of a performance study.
4. Adjudication method for the test set
- Not applicable. No test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human improvement with vs. without AI assistance
- Not applicable. This device is a laser fiber and does not involve AI or human-in-the-loop performance measurement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is a laser fiber and does not involve an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth in the context of a performance study was established. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is a physical medical device (laser fiber) and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
Summary of the Study (as presented in the 510(k)):
The "study" in this context is a substantial equivalence comparison to predicate devices, not a performance study with clinical or non-clinical data generation.
-
Predicate Devices:
-
Methodology: The submission relies on demonstrating that the VAPORMAX™ II Side Firing Fiber has the "same technological characteristics" and "intended use" as the predicate devices.
- Technological Characteristics: The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX™ predicate. It emits laser energy at an approximately 90-degree angle by way of direct reflection, like the UROLASE® predicate. This allows it to be used with up to 100 watts of laser power, consistent with its predicate.
- Intended Use: The intended use for incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers is the same as for its predicates.
-
Conclusion: Based on this comparison, it was concluded that the VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, implying that it is as safe and effective as the legally marketed predicate devices. No new performance data was generated to prove specific acceptance criteria for the new device itself.
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DEC 2 1 2005
VAPORMAX™ II Side Firing Fiber
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.
| I. Submitter Information: | Trimedyne, Inc.15091 Bake ParkwayIrvine, CA 92618949-951-3800 |
|---|---|
| Contact Person: | Glenn YeikPresident and COO |
| Summary Date: | 22 November 2005 |
ll. Device Name
| Proprietary: | VAPORMAX™ II |
|---|---|
| Common: | Laser Fiber |
| Classification: | Accessory to Laser-Powered Instrument |
III. Predicate Device
The predicate devices for the VAPORMAX II Side Firing Fiber are:
- VAPORMAX™ Side Firing Fiber cleared under K050412; and l
- i UROLASE® Right Angle Laser Fiber cleared under K944204, K954597, and K970422.
Device Description IV.
The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
V. Intended Use
The VAPORMAX II is intended for incision, excision, ablation, vaporization, and coagulation of soft tissue and may be used with any cleared Holmium laser that has a compatible connector.
Technological Characteristics VI.
Like its UROLASE predicate, the VAPORMAX II emits laser energy at an approximately 90-degree angle by way of direct reflection. The VAPORMAX II shares most of its design characteristics and all materials with its VAPORMAX predicate and can therefore be used with up to 100 watts of laser power.
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Nonclinical Data VII.
No nonclinical data were submitted in this Premarket Notification.
Clinical Data VIII.
No clinical tests were submitted in this Premarket Notification.
IX. Conclusions
The VAPORMAX II performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2005
Trimedyne, Inc. c/o Morten Simon Christensen Underwriters Laboratories, Inc. 455 East Trimble Road San Jose, California 95131-1230
Re: K053457
Trade/Device Name: VAPORMAX™ II 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: December 12, 2005 Received: December 13, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your section 710(x) prematice from the many tod in interest to englestions for referenced above and have decemined the devices marketed in interstate commerce use stated in the enclosure) to legally maneeds provice Amendments, or to devices that prior to May 28, 1976, the chacitient date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the CPMA >> You may nave been reclassified in accordance with and provincition (PMA). You may.
Act (Act) that do not require approval of a premarket approval application Act. The earger Act (Act) that do flor require approval or a provisions of the Act The general therefore, market the device, subject to the general so anual registration, listing of devices, good controls provisions of the Net merade requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it can h If your device is classified (sec above) into extrement on the may be can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Peacherning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Please be advised that FDA 's issuance of a succeannan vict other requirements of the Act or any
FDA has made a determination that your device complies with semple with all FDA has made a determination that your de rice compress. You must connyly with all
Federal statutes and regulations administered by other Federal CEP Pays 807): Federal statules and regulations administed to: registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration and listing th the Act s requirements, metuding, but not mired more as set forth in the quality labeling (21 CFR Fart 801), good manationing procession is product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systems (QS) regalations (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 5 0 (k) This letter will anow you to begin harketing your antial equivalence of your device to a legally premarket notification. The PDA midnig of sacsament of a mice 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 e If you desire specific advice for your device on our car note the regulation entitled, contact the Office of Compliance at (210) 210 - 1107. Part 807.97). You may obtain other "Misbranding by reference to premarket nonneant (21 cc from the Division of Small Manufacturers,
general information on your responsibilities under the Act 2011 or (201) 143, general information on your responsionities and its toll-free number (800) 638-2041 or (301) 443-6597 or
International and Consumer Assistance at its toll-free number days ht International and Oonsainer Twww.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Buchen
Mark N. Melkerson Acting 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
Kos 3457 510(k) Number (if known):
Device Name: VAPORMAX ™ II
Indications for Use:
The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.
The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer
States of the for the four for that Incor's cloared indications for use, The VAPORMAX II is indicated for use with any oldars with any of as a firmal for use.
Iaser with a compatible connector for that laser's cleared indications for use.
Iaser wi
| Prescription Use | VCAnnual program and any with the company of the first of the first of the first of the first of the first of the first of the first of the first and |
|---|---|
| (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bonekubs for MKM
Division of General, Restorative, and Neurological Devices
Page 1 of 1
3457 510(k) Number_LOS
§ 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.