SEAL ONE

K123035 · Perouse Medical · DXC · Nov 28, 2012 · Cardiovascular

Device Facts

• Record ID: K123035
• Device Name: SEAL ONE
• Applicant: Perouse Medical
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SEAL ONE® is a radial compression device used to manage hemostasis at the puncture site following coronary angiography or angioplasty. The device is placed on the patient's right or left wrist. It features a compression pad driven by an internal screwing mechanism controlled by a compression/decompression knob. The wrist strap is secured via a clip and can be adjusted for length. A time indicator is included to track device placement duration. Decompression is performed by pressing a safety button while turning the knob counter-clockwise. The device is intended for use in clinical settings (coronary and angiography environments) by healthcare professionals. It provides mechanical pressure to the radial artery to facilitate site closure. The strap allows for manual notation of check times. The device benefits patients by providing controlled, adjustable compression to the radial artery puncture site post-procedure.

Clinical Evidence

Bench testing only. Testing included design qualification, biocompatibility, and functional performance (positioning, compression/decompression, and removal) in a simulated coronary/angiography environment.

Technological Characteristics

Radial compression clamp; mechanical compression pad driven by an internal screw system; adjustable wrist strap with clip; manual operation via compression/decompression knob with safety button; non-powered; biocompatible materials.

Indications for Use

Indicated for patients undergoing coronary angiography and angioplasty procedures via radial approach to provide compression at the puncture site.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• TR BAND ™ (K070423)

Submission Summary (Full Text)

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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 - FRANCE<br>Phone [phone]<br>Fax [phone]<br>Website: www.perousemedical.com |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Isabelle JEANTY - Deputy Managing Director, Quality & Regulatory Affairs Director - e-mail :<br>[e-mail] |
| 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 | <b>Indications</b><br>The SEAL ONE® Radial Compression Device is used for coronary angiography and angioplasty procedures practiced for the radial approach to compress the puncture site.<br><br><b>Description</b><br>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.<br><br>Compression is applied by turning the compression knob clockwise.<br><br>Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise.<br><br>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.<br><br><b>Technology</b><br>Compression of the radial artery with a compression pad. The compression pad is driven by the compression/decompression knob (inner screwing system).<br><br>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<br>✓ Biocompatibility<br>✓ Safety and functionality - Bench testing<br>SEAL ONE® Radial compression Device has been submitted to testing during design qualification, in accordance with an internal protocol which is enclosed in this submission:<br>- Aspect<br>- 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.: [phone] Fax : 33 {0}3 44 08 17 01

Division Oncologio & Cardiovasculaire Route du Manoir 60173 Ivry le Temple, France
Tel.: [phone] Fax : [phone]

Division Imagono
Interventionnelle & BtoB
135, Route Neuve 69540 Irigny, France
Tel.: [phone] 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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### 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Myshlll

diovascular Devices

510(%) Numb

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