(167 days)
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.
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.
This is a medical device, not an AI/ML device. The provided text describes a 510(k) premarket notification for a medical device called the "Safeguard™ 24 cm pressure assisted dressing," a hemostasis compression device. The information requested (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, MRMC, standalone performance) is typically associated with studies for AI/ML-powered devices, not for traditional medical devices like the one described here.
Therefore, many of the specific questions about AI/ML device performance and testing are not applicable to the information provided in this document.
However, I can extract information related to the device's intended use and the general types of testing performed to establish substantial equivalence.
Here's a breakdown of the relevant information from the provided text, addressing the questions where possible and noting when a question is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the way one would for an AI/ML model (e.g., minimum accuracy, sensitivity, specificity). Instead, it defines its intended use and then states that clinical testing was conducted to support one of these indications. The "performance" is implicitly deemed acceptable by the FDA's substantial equivalence determination.
| Acceptance Criteria (Stated Indication/Goal) | Reported Device Performance (Implied by study conclusion) |
|---|---|
| Primary Indication: Assist in obtaining and maintaining hemostasis. | "The Safeguard 24 cm pressure assisted dressing is as safe, as effective, and performs as well as the predicate devices." (This statement from the conclusion implies the device successfully assists in obtaining and maintaining hemostasis, similar to its predicates). |
| Secondary Indication: 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. | "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 predicate devices." (This implies the clinical testing supported the claim of reduced active compression time, achieving performance comparable to predicates within the specified parameters.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "Clinical testing" but does not give a number of participants.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states "Clinical testing... was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring expert-established ground truth on a dataset. The "ground truth" for its performance would be direct clinical outcomes (e.g., hemostasis achieved, compression time).
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device for human readers. It's a physical hemostasis device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. It is used by a human clinician. The "standalone" concept doesn't apply.
7. The Type of Ground Truth Used
- The document implies that the ground truth for its clinical testing relates to clinical outcomes such as successful hemostasis and measured active compression time in actual patients.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that is "trained" on data. Its development involved "Requirements specification review," "Performance bench testing," and "Design verification."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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510(k) Summary of Safety and Effectiveness
1.1 :
Volume 1, Section 5
| Date: | February 13, 2007 | |
|---|---|---|
| Submitter: | Interventional Products DivisionDatascope Corp. | FEB 1 4 2007 |
| Contact Person: | Susan E. MandyDirector, Clinical & Regulatory AffairsInterventional Products DivisionDatascope Corp.Telephone: (201)995-8758Fax: (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 SystemK982182 Femostop®IIPlus System | |
| Device Description: | The Safeguard 24 cm pressure assisted dressing is a sterile single use pressurebandage which has a medical grade polyurethane window and bladder, a clearmedical grade PVC flexible fill tube, and a pressure sensitive, self adhesive peelbacking. A luer valve on the end of the fill tube enables a syringe to be connected toinflate 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 thesyringe. The Safeguard 24 cm pressure assisted dressing has a clear window thatfacilities visualization of the access site without removal or manipulation of thedevice. | |
| Intended Use: | The indications for use for the Safeguard 24 cm pressure assisted dressing are toassist in obtaining and maintaining hemostasis. The device is also indicated in thereduction of active compression time in femoral artery cannulation followingdiagnostic and interventional procedures, with an ACT of 140 seconds or less, usingusing a 6 French and smaller sheath size. | |
| Test Summary: | Datascope's product development process required that the following activities becompleted during the development of the Safeguard pressure assisted dressing:Requirements specification reviewPerformance bench testingDesign verificationPage 1 of 2 | |
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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 .
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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.
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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
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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
§ 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).