(8 days)
Not Found
No
The summary describes a fiber optic energy delivery device for use with lasers and does not mention any AI or ML capabilities.
No.
The device is used for surgical procedures such as incision, vaporization, ablation, and coagulation, which are interventional rather than therapeutic.
No.
The VAPORMAX II is described as a surgical device for tissue modification (incision, vaporization, ablation, and coagulation), not for diagnosing conditions.
No
The device description explicitly states it is a "single use, disposable, side firing, fiber optic energy delivery device," which is a hardware component.
Based on the provided information, the VAPORMAX II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers." This is a tool used to deliver energy for surgical purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The VAPORMAX II does not perform this function. It is used on the body.
Therefore, the VAPORMAX II is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 laser with a compatible connector for that laser's cleared indications for use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VAPORMAX II 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
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)
No nonclinical data were submitted in this Premarket Notification.
No clinical tests were submitted in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K050412, K944204, K954597, K970422
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Parkway
Irvine, CA 92618
949-951-3800 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Glenn Yeik
President 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.
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.
IX. Conclusions
The VAPORMAX II performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
2
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.
3
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
4
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 | V
C
Annual 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
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3457 510(k) Number_LOS