disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.

AI/ML Overview

The provided text describes a medical device called "SunmedTM Disposable Angio-Closure Pads" and its 510(k) submission to the FDA. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML or diagnostic devices.

The document primarily focuses on the device's substantial equivalence to a predicate device (Safeguard™ 24cm pressure assisted dressing) based on:

Intended Use: Both assist in obtaining and maintaining hemostasis.
Technological Characteristics: Equivalent in terms of fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

The non-clinical testing performed includes biocompatibility, package penetration, asepsis, aging, EtO and ECH residue, and bench testing. These are primarily related to safety, sterility, and material properties, not performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information in bullet points 1 through 9 because the provided document does not contain data on acceptance criteria, reader studies, ground truth establishment, or performance statistics typically found for diagnostic or AI-enabled medical devices.

The relevant sections of your request that are explicitly or implicitly addressed as "not applicable" in this document are:

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Evaluation was not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Evaluation was not applicable." (implies no standalone performance study in a clinical context)
7. The type of ground truth used: Not applicable as no clinical performance study was done.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

Summary

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March 16, 2020

Sunny Medical Device (Shenzhen) Co.,Ltd. James Zhang General Manager 56 Lehigh Aisle Irvine, California 92612

Re: K191827

Trade/Device Name: SunmedTM Disposable Angio-Closure Pads Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: July 8, 2019 Received: July 8, 2019

Dear James Zhang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Rachel Neubrander, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191827

Device Name

Sunmed disposable angio-closure pads

Indications for Use (Describe)

The Sunmed disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

1.	Submitted by:	Sunny Medical Device (Shenzhen) Co., Ltd.
	Registered Address:	1/F and 401, Zhongtianxin Building B,Longgang District, Shenzhen,
		Guangdong, P.R. China 518172
	Contact Address:	11630 Wilkins Ave, APT # 104Los Angeles, CA 90024USA
	Telephone:	(949)216-8838
	Fax:	(949) 423-0168
	Contact:	JamesQi Zhang, General Manager
	E-mail:	jamesqizhang@gmail.com
	Date:	Mar 7, 2020

1. Proposed Device:

Trade/Proprietary Name:	SunmedTM disposable angio-closure pads
Common/Usual Name:	disposable angio-closure pads
Classification:	II
ClassificationName:	Clamp, Vascular
Regulation Number:	870.4450
Product Code:	DXC

1. Predicate Device:

510(k)Number	Trade Name	Manufacture
K062569	Safeguard™ 24cm pressureassisted dressing	Datascope Corp.

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4. Device description

1. Intended Use
  The Sunmed™ disposable angio-closure pads is to assist in obtaining and maintaining hemnostasis.
1. Technological Comparison to Predicate Device
  The technological characteristics of the subject device, The Sunmed™ disposable angio-closure pads, are equivalent to the Safeguard™ 24cm pressure assisted dressing in terms of intended use, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.
1. Summary of Non-Clinical Testing
  The following tests were performed on the Sunmed™ angio-closure pads:

Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test(two kinds of solvent) Skin sensitization Test (two kinds of solvent) Intracutaneous Reactivity Test (two kinds of solvent) In Vitro Cytotoxicity Test Bacterial endotoxins test

Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing

1. Clinical Evaluation was not applicable.
1. Conclusions

Based on the information presented in this 510(k) premarket notification, the Sunmed™ disposable angio-closure pads is considered substantially equivalent to the Safeguard™ 24cm pressure assisted dressing.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).