The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Device Description

The Pegasus System is a portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver. It is powered by internal batteries encased in a plastic handpiece/handle. The distal tip of the stainless steel probe contains a camera and LED light source for visualization. The device is provided sterile and is intended for single patient use.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Pegasus System," an arthroscope. This submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data, rather than clinical efficacy. Therefore, much of the information typically found in acceptance criteria of an AI/ML medical device (e.g., performance metrics, expert adjudication, MRMC studies) is not applicable here.

The document explicitly states: "No clinical data were required or submitted in support of this submission."

Given this, I cannot provide the full detail for all requested points as they pertain to clinical performance studies, which were not conducted for this specific device clearance.

However, I can extract the information that is present:

1. Acceptance Criteria and Reported Device Performance

Since no clinical efficacy data was submitted, the "acceptance criteria" here refer to meeting established standards for medical device safety and non-clinical performance.

Criterion	Reported Device Performance
Biocompatibility	Meets ISO 10993-1 and ISO 10993-7
Electrical Safety	Meets IEC-60601-1 and EN-60601-1-2 (Electromagnetic Compatibility)
Sterilization	Meets ISO-11135 (Ethylene Oxide Sterilization)
Functional & Performance Requirements	Representative samples meet design requirements (details of specific functional tests not enumerated in this text)
Indications for Use Equivalence	Same as predicate device (K162475)
Technological Equivalence	Nearly identical to predicate (K162475), minor differences (probe diameter, video transmission method) do not affect safety/efficacy.
Safety and Effectiveness Issues	Does not raise any new safety or effectiveness issues.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data. For non-clinical performance testing (biocompatibility, electrical safety, sterilization), it states "representative samples of the device must meet." The exact sample sizes for these tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable as this was non-clinical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth in the context of clinical performance (e.g., disease detection) was not established using experts, as no clinical data was submitted.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as no clinical data was required or submitted. Therefore, there is no information on how human readers might improve with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is an arthroscope, a piece of hardware, not an AI algorithm requiring standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on established industry standards for medical device safety and performance (e.g., ISO, IEC standards for biocompatibility, electrical safety, sterilization) and a comparison to a legally marketed predicate device (K162475). There was no clinical ground truth (e.g., expert consensus, pathology, outcomes data) as clinical data was not submitted.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as it's not an AI/ML device.

Summary

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July 17, 2019

A.M. Surgical, Inc. Vincent Pascale Chief Operations Officer 285 Middle Country Road, Suite 206 Smithtown, New York 11787

Re: K191345

Trade/Device Name: Pegasus System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: May 17, 2019 Received: May 20, 2019

Dear Vincent Pascale:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191345

Device Name

Pegasus System

Indications for Use (Describe)

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.

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K191345

510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for A.M. Surgical, Inc. The logo features a stylized roof-like structure in shades of blue and gray. Below the graphic is the text "A.M. SURGICAL, INC." in a bold, sans-serif font.

Pegasus System

I. SUBMITTER/OWNER

A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787

Establishment Registration: 2437731

Phone: 631-979-9777

Fax: 631-980-4369

Contact Person: Vin Pascale,

Date Prepared: May 17, 2019

II. DEVICE

Tradename of Device: Pegasus System Common or Usual Name: Arthroscope, wireless endoscopic camera system Classification Regulation: 888.1100 Arthroscope Regulatory Class: II Product Code: HRX Special Controls or Device Specific Standards: N/A

III. PREDICATE DEVICE

The subject device is equivalent to the predicate K162475 mi-eye 2. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Pegasus System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

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There are no differences between the Pegasus System and the predicate with respect to indications and intended use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The general device description, intended use, indications for use, visualization method, illumination method, field of view, energy source, video display, probe function, sterility, single use, biocompatibility and electrical safety are the same between the Pegasus System and the predicate device. The minor differences in the probe diameter and method of video transmission do not affect the safety and efficacy of the device. The predicate device has a flushing port and retractable needle design. which do not apply to the Pegasus system.

VII. PERFORMANCE DATA

To verify the design meets it functional and performance requirements, representative samples of the device must meet biocompatibility, electrical and sterilization testing in accordance with the following industry standards.

ISO 10993-1: Biological evaluation of medical devices ●
IEC-60601-1: Medical Electrical Equipment
EN-60601-1-2: Medical Electrical Equipment: General requirements for Basic ● Safety and Essential Performance. Collateral Standard. Electromagnetic Compatibility, requirements and tests.
. ISO-11135: Sterilization of Health Care Products. Ethylene Oxide. Requirements of development, Validation and Routine Control of a Sterilization Process for Medical Devices.
ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide ● Sterilization Residuals

No clinical data were required or submitted in support of this submission.

CONCLUSIONS VIII.

The Pegasus System has the same indications for use and nearly identical technological characteristics to the predicate device (K162475) previously cleared by the FDA. A.M. Surgical has concluded the Pegasus System does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed arthroscopes that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976. This conclusion is based upon the devices' common indications for use, principles of operation, technology, materials and testing standards employed.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.