The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

Device Description

The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.

AI/ML Overview

This document describes a 510(k) premarket notification for the Ningbo DIZENGENS Medical Science Co., Ltd. Radial Compression Device (K232577). The document presents a summary of non-clinical performance testing to support the claim of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document does not provide:

A table of acceptance criteria and reported device performance with specific metrics.
Sample sizes used for a "test set" in the context of an algorithm's performance.
Data provenance, number of experts, adjudication method, or ground truth details for an AI/algorithm study.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Sample size or ground truth establishment for a "training set."

The document primarily focuses on non-clinical performance testing for a physical medical device (a radial compression device), not an AI/software algorithm. The tests conducted are typical for a physical medical device.

Here's a breakdown of what is provided and what elements are missing or not applicable based on the provided text, in the context of your request for AI/algorithm study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Provided: A list of performance tests conducted. For each test, it states "All testing met the requirements and passed."
Missing from provided text: Specific numerical acceptance criteria for each test and the corresponding numerical results obtained by the Radial Compression Device. For example, for "Bond strength testing," it doesn't state "Acceptance criteria: > X N, Result: Y N."

2. Sample size used for the test set and the data provenance:

Not Applicable in the provided text: This question is relevant for AI/algorithm performance evaluation. The document describes tests for a physical device (e.g., visual inspections, bond strength, biocompatibility), not an AI model. Therefore, there's no "test set" of data in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable in the provided text: This question is relevant for AI/algorithm performance. Ground truth for a physical device's non-clinical performance tests is typically established through established engineering standards, laboratory procedures, and physicochemical measurements, not through expert consensus on images or clinical data.

4. Adjudication method for the test set:

Not Applicable in the provided text: This is relevant for AI/algorithm performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No: The document does not mention any MRMC study, as it's for a physical device and not an AI assistant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No: The device is a physical Radial Compression Device, not an algorithm.

7. The type of ground truth used:

Implicitly: For the physical device tests, the "ground truth" is based on engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility and sterilization), and validated laboratory measurements. For instance, biocompatibility is evaluated per ISO 10993, and sterilization per ISO 11135.
Missing from provided text: No explicit mention of ground truth in the context of expert consensus, pathology, or outcomes data, as these are typically for diagnostic AI/software.

8. The sample size for the training set:

Not Applicable: There is no AI/algorithm training set.

9. How the ground truth for the training set was established:

Not Applicable: There is no AI/algorithm training set.

Summary of Provided Non-Clinical Performance Testing:

The provided document lists the following non-clinical performance tests conducted for the Radial Compression Device:

Visual inspections
Dimensional inspections
Bond strength testing
Turn Cap and Screw Function
Distribution and Packaging Tests
Device and Packaging Aging Evaluation
Pressure applied at puncture site (to demonstrate adequate compression)
Biocompatibility evaluation per ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis)
Sterilization (EO gas, SAL of 10-6 per ISO 11135, EO/ECH residuals assessment per 10993-7)

For all of these tests, the document states: "All testing met the requirements and passed."

Conclusion:

The provided text serves as a 510(k) summary for a physical medical device. It details non-clinical performance testing for that physical device to establish substantial equivalence. It does not provide the information requested regarding acceptance criteria and studies for an AI/algorithm device, as the product is not an AI/algorithm.

Summary

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January 18, 2024

Ningbo DIZENGENS Medical Science Co., Ltd. Liqin Wang Floor 3&4. Building A4. No. 777. Binhai 4th Road. Oianwan New Area. Ningbo. Zheijang Province. P.R. China. 315336

Re: K232577

Trade/Device Name: Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: December 5, 2023 Received: December 19, 2023

Dear Liqin Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 E. Neubrander -S

Rachel Neubrander, PhD Division 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

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Indications for Use

510(k) Number (if known) K232577

Device Name Radial Compression Device

Indications for Use (Describe)

The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K232577

A. Submitter Information

Submitter Name: Ningbo DIZENGENS Medical Science Co., Ltd. Submitter Address: Floor 3&4, Building A4, No. 777, Binhai 4th Road, Qianwan New Area, Ningbo, Zhejiang Province, P.R. China. 315336 Phone: +86-574-82359758 Fax: +86-574-82359059

Contact Person: Zhang Wenwei, Vice General Manager Email: edwardzhang@dizegens.com

Date Prepared: January 16, 2024

B. DEVICE

Trade Name: Radial Compression Device Common Name: Radial compression device Classification Name: Vascular Clamp Classification Panel: Cardiovascular Regulation: 21 CFR 870.4450 Classification: Class II Product Code: DXC

C. Predicate Device

The legally marketed device(s) to which substantial equivalence is claimed is the Beijing Demax Medical Technology Co., Ltd. Radial Artery Compression Tourniquets (K222182).

D. Device Description

E. Indications for Use

The Radial Compression Device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

The intended use is the same as the predicate device and does not raise new questions of safety or effectiveness.

F. Comparison of Technological Characteristics

NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD

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The Radial Compression Device and predicate Radial Artery Compression Tourniquets (K222182) affix a hook and loop band onto the patient's wrist following a percutaneous radial artery puncture. Both devices operate by turning a screw, which applies additional force, to the puncture site to achieve temporary hemostasis of the radial artery. The Radial Compression Device incorporates substantially equivalent indications for use, design, operating principles, and sterilization process as those shared by the predicate Radial Artery Compression Tourniquets (K222182).

G. Summary of Non-Clinical Performance Testing

The following performance testing was provided to support substantial equivalence between the Radial Compression Device and the predicate device:

Visual inspections .
Dimensional inspections ●
. Bond strength testing
Turn Cap and Screw Function ●
Distribution and Packaging Tests ●
Device and Packaging Aging Evaluation ●
Pressure applied at puncture site ●
- Testing was conducted to demonstrate that the Radial Compression o Device applies adequate pressure to compress the radial puncture site.

Biocompatibility evaluation per ISO 10993:

Cytotoxicity ●
Sensitization
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Hemolysis ●

Sterilization

The Radial Compression Device is intended for single use only and is provided ● sterile via ethylene oxide (EO) gas to achieve a Sterility Assurance Level (SAL) of 106 per ISO 11135. An EO/ECH residuals assessment found the residuals to be within acceptable limits per 10993-7.
All testing met the requirements and passed.

H. Conclusion

The Radial Compression Device is substantially equivalent to the predicate device.

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).