(24 days)
No
The summary describes a fiber optic energy delivery device for use with lasers, with no mention of AI, ML, image processing, or data analysis capabilities.
No
The device description indicates it is an "energy delivery device" for use with lasers, and its intended uses are surgical procedures like "incision, excision, vaporization, ablation, and coagulation of soft tissue," which are not considered therapeutic but rather interventional or ablative.
No
The VAPORMAX is described as a surgical device for soft tissue procedures like incision, excision, vaporization, ablation, and coagulation, indicating therapeutic rather than diagnostic use.
No
The device description explicitly states that the VAPORMAX is a "single use, disposable, side firing, fiber optic energy delivery device," which is a hardware component.
Based on the provided information, the VAPORMAX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue." This describes a device used on the body during a surgical procedure, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description of a "fiber optic energy delivery device for use with cleared Holmium:YAG lasers" further supports its use in a surgical setting to deliver energy to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues outside the body, or providing diagnostic information based on such analysis.
Therefore, the VAPORMAX is a surgical device, not an IVD.
N/A
Intended Use / 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.
Product codes
GEX
Device Description
The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical use
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)
No nonclinical data were submitted in this Premarket Notification. No clinical tests were submitted in this Premarket Notification. The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K915223, K992230, K022655, K011703, K990947
Reference Device(s)
Not Found
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
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 Parkway
Irvine, CA 92618
949-951-3800 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Glenn Yeik
President 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.
1
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.
2
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