(123 days)
Not Found
No
The device description details a physical system for applying pressure and a hemostatic patch. There is no mention of software, data processing, or any technology that would typically involve AI or ML.
Yes.
The device is used to assist in obtaining and maintaining hemostasis, which is a therapeutic action to stop bleeding.
No.
The device is described as a system "to assist in obtaining and maintaining hemostasis" and "is used to apply direct pressure to obtain and maintain hemostasis." Its function is therapeutic (hemostasis), not diagnostic.
No
The device description clearly lists multiple physical components (patch, support structure, handle, bandage) and describes a manual application process, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Syvekexcel® Vascular Access Hemostasis System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist in obtaining and maintaining hemostasis" following a medical procedure (femoral vascular catheterization). This is a direct therapeutic or procedural application on the patient's body.
- Device Description: The components are physical items used for applying pressure and covering a wound site. They are not used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Syvekexcel® system operates in vivo (on the body) to manage bleeding.
N/A
Intended Use / Indications for Use
Syvekexed® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit:
-
- a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing,
- a disposable Polypropylene support structure, which snaps on to component 3, 2.
-
- a reusable Plexiglas handle, and
-
- a Tegaderm® transparent adhesive bandage
Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral vascular
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)
Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K984177, K040615, K030836, K050146, K973132, K024107, K964663, K021062
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K053300 P5 1 of 2
Marine Polymer Technologies, Inc. Syvekexcel® Vascular Access Hemostasis System
MAR 2 8 2006
VIII. 510(k) Summary
| A. Sponsor/Submitter: | Marine Polymer Technologies, Inc.
107 Water Street
Danvers, MA 01923
Phone: 781-270-3200
Fax: 781-270-1133 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------|
| B. Contact Person | Sergio Finkielsztein
President
Phone: 781-270-3200 x 13 |
| C. Date of Submission: | November 15, 2005 |
| D. Trade (Brand) Name: | Syvekexcel® Vascular Access Hemostasis System |
| E. Common Name: | Topical Hemostasis Pad/Vascular Clamp |
| F. Classification Number/ Name: | 21 CFR § 870.4450 Vascular Clamp |
| G. Regulatory Class: | Class II (two) |
| H. Product Code: | DXC |
I. Predicate Devices:
Marine Polymer Technologies, Inc.- SyvekPatch (K984177) Advanced Vascular Dynamics- CompressAR SuperComfort Disc and Strong Arm SuperComfort System (K040615) Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage (K030836) Vascular Solutions, Inc. D-Stat Clamp Accessory (K050146) TZ Medical- EZ Hold (K973132) RADI Medical Systems- Femostop Femoral Compression System (K024107) RMDS, Inc. Femoral Artery Vascular Pad (K964663) Abbott Vascular Devices - Chito-Seal™ (K021062)
1
J. Intended Use:
Syvekexed® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
K. Device Description:
Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit:
-
- a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing,
- a disposable Polypropylene support structure, which snaps on to component 3, 2.
-
- a reusable Plexiglas handle, and
-
- a Tegaderm® transparent adhesive bandage
Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.
L. Summary of Substantial Equivalence:
Marine Polymer Technologies has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Syvekexcel® Vascular Access Hemostasis System is substantially equivalent to currently marketed predicate devices. Syvekexel" Vascular Access Hemostasis System has essentially the same intended use as the predicate devices. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Marine Polymer Technologies, Inc. c/o Mr. Sergio Finkielsztein President 107 Water Street Danvers, MA 01923
Re: K053300
Syvekexcel® Vascular Access Hemostasis System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: March 3, 2006 Received: March 6, 2006
Dear Mr. Finkielsztein:
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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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, I'DA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Sergio Finkielsztein
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K∅533∅∅
Page 1 of 1
Indications for Use Statement
510(k) Number K053300
Syvekexcel® Vascular Access Hemostasis System Device Name:
Indications for use:
Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
Prescription Use X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Númber K05 3309