(58 days)
No reference devices were used in this submission.
No
The summary describes a basic video camera and light source for visualization, with no mention of AI, ML, image processing beyond basic visualization, or any data processing/analysis capabilities that would typically involve AI/ML. The performance studies focus on standard medical device safety and performance testing (biocompatibility, electrical, sterilization), not AI/ML model validation.
No
The device is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization, which describes a diagnostic or assistive function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures".
No
The device description clearly states it is a "portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver" and includes physical components like a stainless steel probe, camera, LED light source, and internal batteries encased in a plastic handpiece/handle. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Pegasus System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body". This describes a device used directly on or within the body for visual examination and surgical assistance.
- Device Description: The description details a "handheld probe paired with a wireless video receiver" with a camera and light source at the tip. This is consistent with an endoscopic or arthroscopic device used for direct visualization.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens taken from the body (like blood, urine, tissue) to diagnose diseases or conditions. The Pegasus System does not process or analyze such specimens.
- Performance Studies: The performance studies focus on biocompatibility, electrical safety, and sterilization, which are relevant for devices used directly on patients, not for in vitro analysis of specimens.
In summary, the Pegasus System is a device for direct visualization within the body, which falls under the category of medical devices used for diagnosis and treatment in vivo, not in vitro.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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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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
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.