(24 days)
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX 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 is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.
Here's why and what can be extracted based on your request:
- No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
- Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
- Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.
Summary based on available information:
| Aspect | Information from Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided. The document states, "No nonclinical data were submitted" and "No clinical tests were submitted." Conclusions are general: "The VAPORMAX performs as intended and has acceptable mechanical properties." |
| 2. Sample size for test set and data provenance | Not applicable/Not provided. No nonclinical or clinical test data was submitted. The device was cleared based on substantial equivalence to predicate devices, not on new performance data against specific acceptance criteria. |
| 3. Number of experts used to establish ground truth for the test set and their qualifications | Not applicable/Not provided. No test set with ground truth was presented in this submission. |
| 4. Adjudication method for the test set | Not applicable/Not provided. No test set was presented. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of human readers improvement | Not applicable/Not provided. No clinical studies, and therefore no MRMC studies, were submitted or discussed. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | Not applicable/Not provided. This is a physical laser fiber, not an algorithm. |
| 7. The type of ground truth used | Not applicable/Not provided. No test data requiring ground truth was provided. |
| 8. The sample size for the training set | Not applicable/Not provided. There is no mention of machine learning or algorithms that would require a training set. This is a physical medical device. |
| 9. How the ground truth for the training set was established | Not applicable/Not provided. There is no mention of machine learning or algorithms. |
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KOSO412
MAR 1 4 2005
VAPORMAX™ Side Firing Fiber
This summary of 510(k) safety and effectiveness information is being submitted in This Summary of 5 r 6 r 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: | 4 March 2005 |
II. Device Name
| Proprietary: | VAPORMAX TM |
|---|---|
| Common: | Laser Fiber |
| Classification: | Accessory to Laser-Powered Instrument: |
III. Predicate Device
The predicate devices for the VAPORMAX Side Firing Fiber are:
- Trimedyne Side Firing Fibers cleared under 510(k)s K915223, K992230 and . K022655; and
- Lumenis DUOTOME SIDELITE™ believed to have been cleared under K011703 . and/or K990947.
Device Description IV.
The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
Intended Use V.
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX 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.
Technological Characteristics VI.
The VAPORMAX differs from the current Trimedyne side firing devices in that it can be used at laser powers up to 100 watts, rather than 40-60 watts.
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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.
Conclusions Drawn From Testing IX.
The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines representing its wings. The eagle is facing left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Trimedyne, Inc. c/o Mr. Morten S. Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K050412 Trade/Device Name: VaporMAXTM 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: March 4, 2005 Received: March 7, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device within we reviewed your becamed the device is substantially equivalent (for the indications forcreneed above and have sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to commerce prior to may 20, 2012 - 12:00 accordance with the provisions of the Federal Food, Drug. de nees mat have been require approval of a premarket approval application (PMA). and Cosmetic For ( 100) rate the device, subject to the general controls provisions of the Act. The r va may) are severy and 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 any I editar Batales and 2008.
Comply 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 form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Morten S. Christensen
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif anow you to ocgin mailing of substantial equivalence of your device to a legally premaired 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), please if you desire speeme at 75th as a 100 - 10-0115. Also, please note the regulation entitled. Contact the </rive of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Smail other general information of 90% Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Coress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A Milliken
Miriam C. Provost, Ph.D. 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
510(k) Number (if known):
Device Name: VAPORMAX™
Indications for Use:
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX 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.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | 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)
Mark N Milliken
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
§ 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.