(94 days)
The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.
AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has a clear medical grade polyurethane window and bulb that facilitates visualization of the puncture site, a clear medical grade PVC flexible tube, and a pressure sensitive, self-adhesive peel backing. A luer valve on the end of the fill tube enables a luer lock syringe to be connected to inflate and deflate the bulb with air to provide compression of the transradial puncture site.
The provided text describes the Datascope Corp.'s AIR-BAND™ Radial Compression Device, including its intended use, design characteristics, and performance data used for its 510(k) submission. However, it does not contain the specific acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.
The document states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices." and lists the types of testing conducted:
- Biocompatibility Testing
- Pressure Equivalence to Predicate (TR Band)
- Packaging Performance
- Product Stability (Shelf Life)
- Product Sterilization
It concludes that "The results of all testing demonstrate that the AIR-BAND™ Radial Compression Device is as safe, as effective, and performs as well as the predicate devices."
Based on the provided information, I can only provide limited details about the acceptance criteria and study as they are not explicitly detailed in the prompt in the format requested.
Here's an attempt to answer the questions based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria and reported numerical performance values in a table format. It generally states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices" for the listed tests.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Inferred from summary) |
|---|---|
| Device is biocompatible | Met biocompatibility standards |
| Pressure delivery is equivalent to TR Band | Equivalent pressure delivery to TR Band |
| Packaging maintains product integrity | Met packaging performance standards |
| Device maintains stability over shelf life | Met product stability requirements |
| Device is sterile | Met product sterilization requirements |
| Overall safety, effectiveness, and performance equivalent to predicate devices | Demonstrated as safe, effective, and performing as well as predicate devices |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench top testing," but does not specify the sample sizes for these tests. It also does not provide information about the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The testing described is benchtop, not clinical, so "ground truth" in the context of expert review for clinical performance is not applicable here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. As the testing was benchtop, a clinical adjudication method would not be relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned. The device is a physical medical device (radial compression device), not an AI/software product, so this type of study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the benchtop tests, the "ground truth" would be established by validated test methods and specifications relevant to each test (e.g., biocompatibility standards, pressure measurement standards, packaging integrity standards, sterilization standards). No expert consensus, pathology, or outcomes data are mentioned as ground truth.
8. The sample size for the training set
This information is not provided and is not applicable, as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as the device is not an AI/machine learning model.
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S10(K) Summary
100 million in the state
.
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and the comments of ,
Datascope Corp. Premarket Notification Traditional 510(k) AIR-BAND™ Radial Compression Device
| Date: | August 6, 2012 |
|---|---|
| Submitter: | Datascope Corp.15 Law DriveFairfield, NJ 07004 |
| Contact Person: | Carla S. CerqueiraRegulatory Affairs Specialist IIDatascope Corp.Phone: (973) 709-7340Fax: (973) 808-8719helder.sousa@maquetcv.com |
| Device Trade name: | AIR-BAND™ Radial Compression Device |
| Common/Usual Name: | Compression Device |
| Classification Name: | 21 CFR 870.4450 Vascular Clamp |
| Predicate Devices: | K070423 TR Band ™K062569 Safeguard® 24cm Pressure Assisted Dressing |
| Device Description: | AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has aclear medical grade polyurethane window and bulb that facilitates visualization ofthe puncture site, a clear medical grade PVC flexible tube, and a pressuresensitive, self-adhesive peel backing. A luer valve on the end of the fill tubeenables a luer lock syringe to be connected to inflate and deflate the bulb with airto provide compression of the transradial puncture site. |
| Intended Use: | The AIR-BAND™ Radial is a compression device to assist hemostasis of theradial artery after a transradial procedure. |
| Design Characteristics: | The AIR-BAND™ has the same intended use and configuration (wristband) as thepredicate device, TR Band™ (K070423). The materials used are equivalent andthe product design is similar to that of the predicate device Safeguard® 24cmPressure Assisted Dressing (K062569). The AIR-BAND™ is manually operated(inflated/deflated) like both predicate devices. |
| Performance Data: | Bench top testing was used to demonstrate substantial performance equivalenceto the predicate devices. Performance Testing included: |
| NOV 9 2012• Biocompatibility Testing• Pressure Equivalence to Predicate (TR Band)• Packaging Performance• Product Stability (Shelf Life)• Product Sterilization |
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Datascope Corp. Premarket Notification Traditional 510(k) AIR-BAND™ Radial Compression Device
·
Summary: The AIR-BAND™ submitted in this 510(k) has essentially the same intended use, design/ technological and performance characteristics as the predicate devices. The results of all testing demonstrate that the AIR-BAND™ Radial Compression Device is as safe, as effective, and performs as well as the predicate 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 features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 9 2012
Datascope Corp., Cardiac Assist Division % Ms. Carla Cerqueira 15 Law Dr. Fairfield, NJ 07004-0011
Re: K122405
Trade/Device Name: Air-band radial compression device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: October 5, 2012 Received: October 9, 2012
Dear Ms. Cerqueira:
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 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. Carla Cerqueira
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions 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.htm 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 Division 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Matthew G.
Hillebrenner
Bram D. Zuckerman, M.D.
Digitally signed by Matthew G. Hillebrennem
DN:c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300213272,
cn=Matthew G. Hillebrenner
Date: 2012.11.08 16:15:12-05'00
Director
Division of Cardiovascular Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
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Indications For Use
K122405 510(k) Number (if known):
Device Name: AIR-BAND™ Radial Compression Device
Indications For Use:
The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Prescription Use __ X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gus Kleber
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K122405
§ 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).