(44 days)
For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece.
Tattoo Removal
Nevus of Ota
Hair Removal
Vascular Lesions
Dermal Pigmented Lesions
Epidermal Pigmented Lesions
Laser Resurfacing for Acne scars and wrinkles
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
The Compression Tool and Handpiece Attachment Accessories are intended to be used to assist and enhance the procedure of treating dermatological conditions The Compression Tool and Handpiece Attachment Accessories are additional accessories designed to accompany the currently offered MedLite MultiSpot Handpiece. The purpose for these accessories are purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers.
The provided text describes a 510(k) submission for the "HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser Systems". This submission is for accessory devices to an already approved laser system, aimed at reducing purpura during dermatological treatments.
Based on the content of the provided 510(k) summary and FDA letter, the primary focus is on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria, ground truth, or statistical analysis typically associated with AI/software devices. The devices in question are physical accessories (a compression tool and handpiece attachment), not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested categories for AI/software device evaluation are not applicable here.
Here's a breakdown of the information that is available or can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity). The acceptance criteria for this type of submission would primarily revolve around demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This often involves engineering bench testing and potentially limited human factors evaluations for new accessories, rather than clinical efficacy studies with specific performance targets.
- Reported Device Performance: The submission states that the purpose of the accessories is "purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers." The "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device, which also aims to manage purpura. No specific numerical performance results (like "purpura reduction by X%") are provided.
| Acceptance Criteria (Inferred for Substantial Equivalence of a Physical Accessory) | Reported Device Performance |
|---|---|
| Safety: Device operates safely without new risks. | Not explicitly detailed but implied to be safe by substantial equivalence. |
| Effectiveness: Device performs its intended function (assisting purpura reduction). | Intended to "help reduce undesirable purpura." No quantitative measure reported. |
| Technological Characteristics: Similar to predicate device. | Not explicitly detailed but implied by substantial equivalence comparisons. |
| Intended Use: Consistent with predicate device. | "For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece." Consistent with predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a hardware accessory (compression tool and handpiece attachment) for a laser system, not a software or AI device that would typically rely on a "test set" of data or patient images for performance evaluation in the context of sensitivity/specificity. The evaluation would have been engineering/bench testing for safety and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2. Ground truth is not established in the same way for a physical accessory as it would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical accessory to a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The evaluation of these accessories likely focused on their mechanical fit, durability, and ability to apply compression without adverse effects, rather than a diagnostic ground truth. Safety and performance conformity to standards and predicate device characteristics would be the "ground truth" for this type of submission.
8. The sample size for the training set
- Not Applicable. This is a hardware accessory and does not involve AI training.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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510(k) Summary or 510(k) Statement 5.
Medite C6 Q-Switched Nd: YAG Laser Medlite Compression Tool and Handpiece Attachment Accessories 510k Summary
Image /page/0/Picture/4 description: The image shows the logo for HOYA ConBio. Below the logo is the address 47733 Fremont Boulevard, Fremont, California 94538. The address is printed in a smaller font than the logo.
510-445-4500 www.conbio.com 510-445-4550 Fax
| Submitter: | Hoya ConBio, Inc.47733 Fremont Blvd.Fremont, California 94538Phone: 510-445-4500Fax: 510-445-4550 |
|---|---|
| Contact: | Mr. Jim GreenVice President of Engineering |
| Date Summary Prepared: | March 28, 2006 |
| Device Trade Name: | Medlite ™ Nd: YAG Laser System: Compression Tool andHandpiece Accessory |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.4810 |
| Equivalent Device: | Candela Pigmented Lesion Compression HandpieceAccessory - K051359Medlite ™ C6 Q-Switched Nd: YAG Laser / StandardMultiSpot ™ Handpiece Accessory - K014234 |
| Device Description: | The Compression Tool and Handpiece AttachmentAccessories are intended to be used to assist and enhancethe procedure of treating dermatological conditions TheCompression Tool and Handpiece Attachment Accessoriesare additional accessories designed to accompany thecurrently offered MedLite MultiSpot Handpiece. Thepurpose for these accessories are purely for a cosmetic endto help reduce undesirable purpura while treating with theMedlite C Series lasers. |
| Intended Use: | For use in dermatology for all currently approved indicationsfor the Medlite C-Series Nd: YAG Laser Systems andMultiSpot Handpiece. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it consists of a staff with two snakes coiled around it and wings at the top. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
Hoya ConBio™ % Mr. Jim Green Vice President of Engineering 47733 Fremont Boulevard Fremont, California 94538
Re: K060977
Trade/Device Name: HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser Systems 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: April 6, 2006 Received: April 10, 2006
Dear Mr. Green:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (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
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Page 2 - Mr. Jim Green
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 product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson 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 Statement 4.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
HOYA ConBio Compression Tool and Handpiece Accessories for use with the MedLite™ C Series Q- Switched Nd: YAG Laser Systems.
Indications for Use: Tattoo Removal
Nevus of Ota Hair Removal Vascular Lesions Dermal Pigmented Lesions Epidermal Pigmented Lesions Laser Resurfacing for Acne scars and wrinkles Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (Division Sign-Villancurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative,
and Neurological Devices
Page of (Posted November 13, 2003)
510(k) Number_koso977
Page 15 of 83
§ 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.