(88 days)
The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue.
The A.R.C. Laser Surgery Fibers & Probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
The A.R.C. surgical laser fibers & probes are single use laser delivery devices provided EO sterile and intended for medical applications in various fields of laser surgery. The devices are based on a quartz core, have a length of 6.5 feet (2 meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode. The distal end have a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.
The provided document is a 510(k) premarket notification for the A.R.C. Laser Surgical Fibers & Probes. It describes the device's intended use and claims substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for a device performance study or the details of such a study as typically required for AI/ML medical devices.
The document details performance bench testing for the physical characteristics of the fibers and their packaging/sterilization, but not a study of clinical performance or algorithm performance. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets them in the context of AI/ML.
Here's why I cannot fulfill your request based on the provided text:
- No AI/ML Component: The device described is a physical laser fiber and probe. There is no mention of an AI/ML algorithm or software component.
- No Performance Metrics like Sensitivity, Specificity, AUC: The "performance" section discusses bench tests related to the physical integrity, energy transmission, and sterility of the fibers. It does not mention clinical performance metrics that would be associated with an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy, F1-score, AUC).
- No Clinical Study Details: The document explicitly states "Clinical Performance data: None." This means there was no clinical study conducted or submitted as part of this 510(k) to evaluate the device's performance in a clinical setting with human subjects.
- No Ground Truth Establishment: Since there isn't a clinical performance study involving diagnostic or prognostic outputs, there's no ground truth to be established by experts or pathology.
Summary of what can be extracted, demonstrating why the requested information for an AI/ML device is not present:
- Table of acceptance criteria and reported device performance: Not available for AI/ML performance. The document lists physical bench tests and standards/guidelines (e.g., ASTM F1886/F1886M-09: 2013 for packaging).
- Sample size used for the test set and data provenance: Not applicable. No test set for AI/ML.
- Number of experts used to establish the ground truth...: Not applicable. No ground truth for AI/ML.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion: The provided FDA 510(k) clearance letter and summary pertain to a physical medical device (laser fibers and probes) and do not include the type of information requested for evaluating an AI/ML medical device's performance or its associated studies.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with a stylized eagle above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16. 2016
A.R.C. Laser GmbH Ms. Angela Thyzel CEO Bessemer St. 14 Nurnberg, 90411 Germany
Re: K161403 Trade/Device Name: A.R.C. Laser Surgical Fibers And Probes Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: Mav 20, 2016 Received: May 20, 2016
Dear Ms. Thyzel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Post-market Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161403
Device Name
A.R.C Laser Surgery Fibers and Probes
Indications for Use (Describe)
The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, hemostasis or coagulation of soft tissue.
The A.R.C laser surgery fibers and probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image features the logo for A.R.C. Laser, set against a solid blue background. The acronym "A.R.C." is prominently displayed in large, bold white letters, stacked above the word "LASER," which is enclosed in a white box. Below this, the tagline "enlighten your surgery." is written in a smaller, italicized font, completing the logo's design.
Section 5 - 510(k) SUMMARY
| Title: | A.R.C. Laser Surgical Laser Fibers & Probes |
|---|---|
| Submitter: | A.R.C. Laser GmbHBessemer St. 1490411, NurnbergGermany |
| Contact : | Angela Thyzel |
| Tittle : | General Manager |
| Phone : | 0911-21779-0 |
| Fax : | 0911-21779-99 |
| E-Mail: | a.thyzel@arclaser.de |
| Address: | Bessemer St. 1490411, NurnbergGermany |
| Date Prepared: | May 15, 2016 |
| Device Trade Name: | A.R.C. Laser Surgical Laser Fibers & Probes |
| Common Name: | Fiber Optic laser delivery system |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and indermatology |
| Device product code: | GEX |
| Device Classification | 21 CFR 878.4810 |
| Predicate Devices: | Adler MicroMed Surgical Laser Fibers (K152417) |
| Device Description: | The A.R.C. surgical laser fibers & probes are single use laser deliverydevices provided EO sterile and intended for medical applicationsin various fields of laser surgery.The devices are based on a quartz core, have a length of 6.5 feet (2meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to2100nm. |
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Image /page/4/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with "LASER" in a smaller font size directly below it. Underneath the word "LASER" is the tagline "enlighten your surgery" in a smaller, italicized font.
The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode.
The distal end have a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.
Intended
Use:
The A.R.C. laser surgery fibers & probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue.
The A.R.C. Laser Surgery Fibers & Probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
Substantial
Equivalence:
The A.R.C. laser surgery fibers & probes have the same mechanism of action, same intended use and the same technological characteristics as the predicate devices, the Adler MicroMed Laser Surgery Fibers, K152417.
Thus, we conclude that the A.R.C. Laser Surgery Fibers & Probes are as safe and effective as the predicate devices.
Performance
Bench Testing : The A.R.C. laser surgery fibers & probes are single use and sterile medical devices, thus the following tests have been performed
| Test | Standard/ Guidelines | Section in submission |
|---|---|---|
| Bench, functional tests | Internal methods | Section 11Fibers functional aging testFibers Energy transmission validation |
| Sterile packaging test:Visual packaging integrity testSealing strength validationMicrobial barrierPeel test | ASTM F1886/F1886M-09: 2013ASTM F1980-07:2001ASTM F1608-00:2009DIN EN ISO 11737-2:2014DIN EN 868:2009ISO 10993-1:2009(R) 2013EN ISO 11607-1 | Section 13PackagingShelf Life |
| Sterilization validation | DIN EN ISO 11135-1:2014ISO 10993-7: 2009 | Section 14Appendix 8-SterilizationValidation -EO Residuals |
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Image /page/5/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" directly underneath in a smaller font. Below that, the tagline "enlighten your surgery" is written in a cursive font.
The performance testing demonstrated that the A.R.C. laser surgery fibers & probes are as safe and as effective as the cleared predicate devices.
Clinical Performance None data:
§ 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.