(61 days)
Not Found
No
The device description and performance studies focus on mechanical compression and manual operation, with no mention of AI or ML.
No
The device is used to compress a puncture site after a medical procedure, not to treat a disease or condition itself.
No
The device is described as a radial compression device used to compress a puncture site after coronary angiography and angioplasty procedures. Its function is to apply pressure to stop bleeding, not to diagnose a condition or disease.
No
The device description clearly details physical components like a wrist strap, compression knob, and safety button, indicating it is a hardware device for applying physical compression.
Based on the provided information, the SEAL ONE Radial compression Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to compress a puncture site after coronary angiography and angioplasty procedures performed via the radial approach. This is a physical intervention applied to the patient's body.
- Device Description: The description details a mechanical device used for external compression. It involves straps, a knob for compression, and a time indicator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are devices used in vitro (outside the body) to analyze biological samples. The SEAL ONE device is used in vivo (on the body) for physical compression.
N/A
Intended Use / Indications for 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.
The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.
Product codes
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance data included with this submission
✓ Biocompatibility
✓ Safety and functionality - Bench testing
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:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
Phone +33(0)4 72 39 74 14
Fax +33(0)4 78 51 89 67
Website: 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 | Indications
The SEAL ONE® Radial Compression Device is used for coronary angiography and angioplasty procedures practiced for the radial approach to compress the puncture site.
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.
Technology
Compression 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 testing
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:
- 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol. The logo is presented in black and white.
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
3
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
4
510k Premarket Notification SEAL ONE® Radial Compression Device September 2012
Image /page/4/Picture/1 description: The image shows the words "PEROUSE MEDICAL" in a stacked format. The word "PEROUSE" is in a bold, sans-serif font, and the word "MEDICAL" is in a thinner, sans-serif font. The letters are black against a white background. The image appears to be a logo or heading.
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
510(%) Numb
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