(154 days)
The IRIDERM Apex 800 is indicated for hair removal.
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming.
The provided text is a 510(k) summary for the IRIDERM Apex 800, a laser system for hair removal. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Based on the information provided in the text, here's a breakdown regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The 510(k) summary focuses on establishing substantial equivalence to predicate devices, rather than defining and testing against specific acceptance criteria for performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Test Set: Not applicable. The document explicitly states: "Non-Clinical performance Data: None" and "Clinical performance Data: None". Therefore, there was no test set in the context of performance data collection for this submission. The substantial equivalence was based on technological similarity to predicate devices.
- Data Provenance: Not applicable, as no performance data was presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No test set was used, and thus no ground truth was established by experts for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- MRMC Study: No. The document explicitly states: "Clinical performance Data: None".
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a laser system, not an AI algorithm. The concept of "standalone performance" in the context of an algorithm does not apply here.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. As acknowledged in points 2, 3, and 4, there was no performance data or test set presented to establish a ground truth. The submission relies on establishing substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical medical device (laser system), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML algorithm requiring a training set.
Summary of Acceptance Criteria and Study:
The provided 510(k) summary for the IRIDERM Apex 800 does not describe any specific acceptance criteria or an inferential study to prove that the device meets those criteria.
Instead, the submission relies entirely on demonstrating substantial equivalence to existing predicate devices (Cynosure, Inc., PhotoGenica LPIR (K971737) and Coherent, Inc., LightSheer (K973324)) already on the market for the indication of hair removal. The argument for substantial equivalence is based on:
- Similar Intended Use: All devices are indicated for hair removal.
- Similar Technological Characteristics: The IRIDERM Apex 800 is a semiconductor diode laser system delivering infrared 800 nm light, with comparable spot sizes, pulse durations, and energy densities to the predicate devices. The document directly compares these specifications across all three devices.
The text explicitly states: "Non-Clinical performance Data: None" and "Clinical performance Data: None." This means the submission did not include new performance studies (either non-clinical or clinical) to establish safety and effectiveness against specific acceptance criteria. The FDA's clearance (DEC - 9 1999 letter) indicates that they reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed devices, allowing it to proceed to market without new performance data.
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K992298
DEC - 9 1999
510(k) Summarv IRIDEX Corporation IRIDERM Apex 800
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Bradlev J. Renton, Ph.D. IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8100
Contact Person: (same as above)
Date Prepared: July 2, 1999
Name of Device and Name/Address of Sponsor
IRIDERM Apex 800
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: 79 GEX
Predicate Devices
The IRIDERM Apex 800 Dermatology Laser System is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324).
Device Description
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming.
Intended Use
The IRIDERM Apex 800 is indicated for hair removal.
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Technological Characteristics and Substantial Equivalence
The IRIDERM Apex 800 is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). These predicate devices are indicated for hair removal.
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm² for spot sizes of 7, 8.5 and 10 mm respectively.
The Cynosure, Inc., PhotoGenica LPIR (K971737) delivers pulsed infrared 755 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 20 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40 and 25 J/cm² for spot sizes of 7 and 10 mm respectively.
The Coherent, Inc., LightSheer (K973324) is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into a 9 mm square treatment spot. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is 40 J/cm2.
Non-Clinical performance Data: None
Clinical performance Data: None
Conclusion
The IRIDERM Apex 800 is substantially equivalent to predicate devices currently legally marketed for the indication of hair removal.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Bradley J. Renton, Ph.D. Vice President, Dermatology IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043
Re: K992298 Trade Name: IRIDERM Apex 800 Regulatory Class: II Product Code: GEX Dated: September 29, 1999 Received: September 30, 1999
Dear Dr. Renton :
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Bradley J. Renton, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | Pending K992279 |
|---|---|
| --------------------------- | ----------------- |
Device Name: IRIDERM Apex 800
Indications For Use:
The IRIDERM Apex 800 is indicated for hair removal.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcoellyo
(Division Sign-Off)
Division of General Restorative Devices K992298
510(k) Number
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.