The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.

Device Description

The SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it. Compression is applied by turning the compression knob clockwise. Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise. It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.

AI/ML Overview

The PEROUSE MEDICAL SEAL ONE® Radial Compression Device is intended for use in coronary angiography and angioplasty procedures to compress the puncture site when a radial approach is used. The device's performance was evaluated through various preclinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility	Met biocompatibility requirements (demonstrating safety in terms of biological interactions).
Safety and Functionality - Bench Testing	The device successfully underwent testing during design qualification, in accordance with an internal protocol. This included evaluation of:
- Aspect	The physical appearance of the device met specified requirements.
- Preparation of the system	The device could be prepared for use as intended.
- Positioning of the system on the wrist	The device could be correctly positioned on the wrist.
- Compression / decompression functionality	The compression and decompression mechanisms operated as designed (i.e., turning the knob clockwise for compression, and simultaneously pressing the safety button and turning anticlockwise for decompression).
- Device positioned and functioning	The device remained correctly positioned and functioned effectively during use.
- Removal of the device at the end of process	The device could be safely and easily removed after the procedure.
- Used on a patient in the coronary and angiography environment	The device demonstrated functionality and suitability for use in a clinical (coronary and angiography) environment, though details of this "use" are not elaborated as a formal patient study.

Study Details:

The provided summary describes a submission for 510(k) clearance, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (TR BAND™) and thorough preclinical testing rather than a clinical trial with a large test set of patient data.

2. Sample size used for the test set and the data provenance:
The document does not specify a patient-based test set size or data provenance for evaluating the device's performance through a clinical study. The performance data listed (biocompatibility, safety and functionality bench testing, and "used on a patient in the coronary and angiography environment") appear to be from preclinical and possibly limited clinical observations (without formal study design details). The reference to "used on a patient" is vague and does not indicate a structured sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given the nature of the tests (bench testing), external expert adjudication of ground truth in the traditional sense would not be applicable in the same way it would be for diagnostic AI. The "ground truth" for bench tests is adherence to design specifications and functional requirements.
4. Adjudication method for the test set:
An adjudication method like 2+1 or 3+1 is not applicable as there was no formal clinical study with a test set requiring independent assessment of outcomes. The evaluation involved successful completion of predefined internal protocols for bench testing and potentially observational use.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was performed or is relevant to this device. This device is a radial compression device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the SEAL ONE® is a physical medical device, not a software algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance was based on engineering specifications, functional requirements, and internal test protocols. For biocompatibility, it would be adherence to relevant ISO standards. For functionality, it was the successful operation of the device as designed during bench testing.
8. The sample size for the training set:
This question is not applicable as there is no mention or implication of a training set, as the device is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated above.

Summary

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K123035

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

NOV 2 8 2012

Submitter	PEROUSE MEDICAL – 135 route neuve – 69540 Irigny - FRANCEPhone +33(0)4 72 39 74 14Fax +33(0)4 78 51 89 67Website: www.perousemedical.com
Contacts	Isabelle JEANTY - Deputy Managing Director, Quality & Regulatory Affairs Director - e-mail :i.jeanty@perousemedical.com
Preparation date	August 28 2012
Trade Name	SEAL ONE® Radial Compression Device
Common Name	Radial Compression Device
Classification Name	clamp, vascular
Legally marketed predicate devices	TR BAND ™, 510(k) N° K070423
Description	IndicationsThe SEAL ONE® Radial Compression Device is used for coronary angiography and angioplasty procedures practiced for the radial approach to compress the puncture site.DescriptionThe SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it.Compression is applied by turning the compression knob clockwise.Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise.It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.TechnologyCompression of the radial artery with a compression pad. The compression pad is driven by the compression/decompression knob (inner screwing system).The decompression is made to press the safety button turning the compression knob simultaneously anti-clockwise.
Intended Use	The SEAL ONE® Radial Compression Device is used for coronary angiography and angioplasty procedures practiced for the radial approach to compress the puncture site.
Performance data	Performance data included with this submission✓ Biocompatibility✓ Safety and functionality - Bench testingSEAL ONE® Radial compression Device has been submitted to testing during design qualification, in accordance with an internal protocol which is enclosed in this submission:- Aspect- Preparation of the system
	- Positioning of the system on the wrist
	- Compression / decompression of the puncture site
	- Device positioned and functioning
	- Removal of the device at the end of process
	- Used on a patient in the coronary and angiography environment
Substantial equivalence	SEAL ONE® Radial Compression Device is substantially equivalent to TR BAND™
Conclusion	Performance data demonstrate safety, effectiveness and substantial equivalence

Sibgo sodal Route du Manoir 60173 Ivry le Temple, France Tel.: 33 (0)3 44 08 17 00 Fax : 33 {0}3 44 08 17 01

Division Oncologio & Cardiovasculaire Route du Manoir 60173 Ivry le Temple, France
Tel.: 33 (0)3 44 08 17 00 Fax : 33 (0)3 44 08 17 01

Division Imagono
Interventionnelle & BtoB
135, Route Neuve 69540 Irigny, France
Tel.: 33 (0)4 72 39 74 14 Fax : 33 (Q)4 78 51 89 67

www.perousemodleal.com SAS au caprul de 1316702 curse

SIREN 317 200 939 RCS Beauwsia N' TVA intra:communautaits :
FR 01 317 883 939

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PERQUSE
MEDICAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NOV 2 8 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Perouse Medical C/O Isabelle Jeanty Deputy Managing Director Quality/Regulatory Affairs Director 135 Route Neuve 69540 Irigny, France

Re: 510(k) Number: K123035

Trade/Device Name: SEAL ONE Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 25, 2012 Received: September 28, 2012

Dear Ms. Jeanty:

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. 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

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Page 2 – Ms. Isabelle Jeanty

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Fee o requirements (1); medical device reporting (reporting of medical CI N Fart 607); adoling (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overses (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for go to mep. WWW.laagem . Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertor Devices and Radiersground ing by reference to premarket notification" (21CFR Part now the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the rou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510k Premarket Notification SEAL ONE® Radial Compression Device September 2012

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INDICATIONS FOR USE

510(k) Number (if known): K/23035 Device Name: SEAL ONE

Indications for Use:

The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site. .

Prescription Use ﻪ ﺍ (Part 21 CFR 801 Subpart D)

AND/ OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myshlll

diovascular Devices

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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).