Pegasus System

K191345 · A.M. Surgical, Inc. · HRX · Jul 17, 2019 · Orthopedic

Device Facts

• Record ID: K191345
• Device Name: Pegasus System
• Applicant: A.M. Surgical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

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 Story

Pegasus System is a portable, disposable, rigid, handheld probe with integrated video camera and LED light source; paired with wireless video receiver. Device powered by internal batteries within plastic handle; stainless steel probe tip provides visualization. Used in clinical settings for diagnostic and operative arthroscopic/endoscopic procedures. Physician operates device to visualize interior body cavities; output displayed on external monitor. Enables real-time visualization for surgical guidance; benefits patient through minimally invasive diagnostic/operative access.

Clinical Evidence

No clinical data were required or submitted. Bench testing only, including biocompatibility (ISO 10993-1, ISO 10993-7), electrical safety/EMC (IEC-60601-1, EN-60601-1-2), and sterilization validation (ISO-11135).

Technological Characteristics

Portable, disposable, rigid handheld probe. Materials: stainless steel probe, plastic handle. Illumination: LED. Energy: internal battery. Connectivity: wireless video transmission. Sterilization: Ethylene Oxide (ISO-11135). Standards: ISO 10993-1, ISO 10993-7, IEC-60601-1, EN-60601-1-2.

Indications for Use

Indicated for diagnostic and operative arthroscopic and endoscopic procedures requiring illumination and visualization of interior body cavities via natural or surgical openings.

Regulatory Classification

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.

Predicate Devices

• mi-eye 2 (K162475)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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)

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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:

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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: [phone]

Fax: [phone]

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

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.

#### 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.