(94 days)
No
The device description and performance studies focus on mechanical compression and material properties, with no mention of AI/ML terms or functionalities.
No
The device is described as a "compression device to assist hemostasis," which is a supportive function rather than a direct therapeutic treatment of a disease or condition. It helps manage a complication (bleeding) after a procedure, but doesn't treat an underlying disease.
No.
The device description states its purpose is to provide compression for hemostasis; it does not mention diagnosing any condition.
No
The device description clearly outlines physical components such as a polyurethane window, PVC tube, adhesive backing, and a luer valve, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist hemostasis of the radial artery after a transradial procedure. This is a therapeutic/hemostatic function performed directly on the patient's body.
- Device Description: The description details a mechanical compression device that applies pressure externally.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (on the body) for a physical purpose.
N/A
Intended Use / Indications for Use
The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Product codes
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial 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)
Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices. Performance Testing included:
• Biocompatibility Testing
• Pressure Equivalence to Predicate (TR Band)
• Packaging Performance
• Product Stability (Shelf Life)
• Product Sterilization
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070423 TR Band ™, K062569 Safeguard® 24cm Pressure Assisted Dressing
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
S10(K) Summary
100 million in the state
.
: 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、
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 Drive | |
| Fairfield, NJ 07004 |
|
| Contact Person: | Carla S. Cerqueira
Regulatory Affairs Specialist II
Datascope Corp.
Phone: (973) 709-7340
Fax: (973) 808-8719
helder.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 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. |
| Intended Use: | The AIR-BAND™ Radial is a compression device to assist hemostasis of the
radial artery after a transradial procedure. |
| Design Characteristics: | The AIR-BAND™ has the same intended use and configuration (wristband) as the
predicate device, TR Band™ (K070423). The materials used are equivalent and
the product design is similar to that of the predicate device Safeguard® 24cm
Pressure 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 equivalence
to 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 |
1
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. .
' · ·
2
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
3
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
4
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