(167 days)
Not Found
No
The device description and performance studies focus on mechanical pressure and visualization, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated to "assist in obtaining and maintaining hemostasis" and "in the reduction of active compression time in femoral artery cannulation," which constitute therapeutic actions.
No.
The device's intended use is to assist in obtaining and maintaining hemostasis and to reduce active compression time in femoral artery cannulation following procedures, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a bandage, polyurethane window and bladder, PVC fill tube, and adhesive backing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Safeguard 24 cm pressure assisted dressing is a physical device applied externally to the body (specifically, the femoral artery access site) to apply pressure and assist with hemostasis. It does not analyze any biological specimens.
- Intended Use: The intended use is to assist in obtaining and maintaining hemostasis and reduce active compression time. This is a mechanical function, not a diagnostic one based on analyzing biological samples.
Therefore, the device described is a therapeutic/mechanical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use for the Safeguard 24 cm pressure assisted dressing are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures, with an ACT of 140 seconds or less, using a 6 French and smaller sheath size.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Safeguard 24 cm pressure assisted dressing is a sterile single use pressure bandage which has a medical grade polyurethane window and bladder, a clear medical grade PVC flexible fill tube, and a pressure sensitive, self adhesive peel backing. A luer valve on the end of the fill tube enables a syringe to be connected to inflate the centrally located bladder with air to provide pressure to the puncture site. A check valve allows the fill volume to stay in the bladder after injection from the syringe. The Safeguard 24 cm pressure assisted dressing has a clear window that facilities visualization of the access site without removal or manipulation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
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)
Datascope's product development process required that the following activities be completed during the development of the Safeguard pressure assisted dressing: Requirements specification review, Performance bench testing, Design verification. Clinical testing with the Safeguard 24 cm pressure assisted dressing was conducted in support of the indication for reduction of active compression time in femoral artery compression following diagnostic and interventional procedures. The results of all testing demonstrate that the Safeguard 24 cm pressure assisted dressing is as safe, as effective, and performs as well as the prodicate devices.
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.
K053300 Syvekexcel® Vascular Access Hemostasis System, K982182 Femostop®IIPlus System
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
:
i
:
:
510(k) Summary of Safety and Effectiveness
1.1 :
Volume 1, Section 5
| Date: | February 13, 2007 | |
|---|---|---|
| Submitter: | Interventional Products Division | |
| Datascope Corp. | FEB 1 4 2007 | |
| Contact Person: | Susan E. Mandy | |
| Director, Clinical & Regulatory Affairs | ||
| Interventional Products Division | ||
| Datascope Corp. | ||
| Telephone: (201)995-8758 | ||
| Fax: (201) 995-8992 | ||
| Device trade name: | Safeguard™ 24 cm pressure assisted dressing | |
| Common/usual name: Hemostasis Compression Device | ||
| Classification names: 21 CFR 870.4450 Vascular clamp | ||
| Predicate Devices: | K053300 Syvekexcel® Vascular Access Hemostasis System | |
| K982182 Femostop®IIPlus System | ||
| Device Description: | The Safeguard 24 cm pressure assisted dressing is a sterile single use pressure | |
| bandage which has a medical grade polyurethane window and bladder, a clear | ||
| medical grade PVC flexible fill tube, and a pressure sensitive, self adhesive peel | ||
| backing. A luer valve on the end of the fill tube enables a syringe to be connected to | ||
| inflate the centrally located bladder with air to provide pressure to the puncture site. | ||
| A check valve allows the fill volume to stay in the bladder after injection from the | ||
| syringe. The Safeguard 24 cm pressure assisted dressing has a clear window that | ||
| facilities visualization of the access site without removal or manipulation of the | ||
| device. | ||
| Intended Use: | The indications for use for the Safeguard 24 cm pressure assisted dressing are to | |
| assist in obtaining and maintaining hemostasis. The device is also indicated in the | ||
| reduction of active compression time in femoral artery cannulation following | ||
| diagnostic and interventional procedures, with an ACT of 140 seconds or less, using | ||
| using a 6 French and smaller sheath size. | ||
| Test Summary: | Datascope's product development process required that the following activities be | |
| completed during the development of the Safeguard pressure assisted dressing: | ||
| Requirements specification review | ||
| Performance bench testing | ||
| Design verification | ||
| Page 1 of 2 | ||
1
Clinical testing with the Safeguard 24 cm pressure assisted dressing was conducted in support of the indication for reduction of active compression time in femoral areery compression following diagnostic and interventional procedures.
Conclusion:
The Safeguard 24 cm pressure assisted dressing has essentially the same intended use as the predicate devices. Datascope Corp. has submitted test results regarding biocompatibility, performance and clinical testing to establish that the Safeguard 24 crupressure assisted dressing is substantially equivalent to the predicate devices. The results of all testing demonstrate that the Safeguard 24 cm pressure assisted dressing is as safe, as effective, and performs as well as the prodicate devices .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element beneath them.
Public Health Service
DEC - 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Datascope Ms. Denise Daugert Interventional Products Division 1300 MacArthur Blvd Mahwah, NJ 07430-0605
Re: K062569
Trade/Device Name: Safeguard™ 24 cm pressure assisted device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: February 14, 2007 Received: February 14, 2007
Dear Ms. Daugert:
This letter corrects our substantially equivalent letter of February 14, 2007.
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 either 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, FDA may publish further announcements concerning your device in the Federal Register.
3
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 (QS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blyumina for
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
K062569 510(k) Number:
Safeguard™ 24 cm pressure assisted device Device Name:
Indications For Use:
The indications for use for the Safeguard 24 cm pressure assisted device are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures with an ACT of 140 seconds or less, using a 6 French and smaller sheath size.
Over-The-Counter Use ------Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Bhumima fr
D of Cardiovascular Devices
510(k) number K061569