(82 days)
Not Found
No
The device description and performance studies focus on the physical components and standard testing of blood pressure cuffs and accessories, with no mention of AI or ML algorithms.
No.
The device's purpose is to measure blood pressure, not to treat a condition.
No
Explanation: The device described is an accessory (cuffs, hoses, adapters) for non-invasive blood pressure systems. It is used to measure blood pressure, which provides data for diagnosis but does not itself perform a diagnostic function. It is a measurement tool, not a diagnostic device.
No
The device description explicitly details physical components (cuffs, hoses, adapters) and their materials and construction, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for noninvasive blood pressure systems. These systems measure blood pressure directly on the patient's body (in vivo).
- Device Description: The description details physical components like cuffs, hoses, and adapters used to connect to a blood pressure system. There is no mention of analyzing samples taken from the body (in vitro).
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a medical accessory used for a non-invasive physiological measurement.
N/A
Intended Use / Indications for Use
The Advantage Cuff is an accessory that is intended to be used with manual or automated noninvasive sphygmomanometers. The cuff makes no diagnosis. The cuffs are provided non-sterile and may be reused. The cuff is not designed, sold or intended for use except as indicated.
The NIBP Hose and Adapters are accessories that are intended to be used with manual or automated noninvasive sphygmomanometers. They make no diagnosis. The hoses and adapters are provided non-sterile and may be reused. The hose and adapters are not designed, sold or intended for use except as indicated.
AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIBP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The Advantage Cuff, NIBP Hose and Adapters are accessories for noninvasive blood pressure systems.
Cuff: The cuff is comprised of an air tight bladder enclosed in an inelastic sleeve with one or two tubes and the appropriate connectors for the type device required. The Advantage Cuffs come in a range of sizes, each marked with the appropriate limb circumference for which the cuff is intended.
Hose: The hose is comprised of single or dual tubing, in various lengths as required by the customer or application, with the appropriate connectors attached to each end of the tubing.
Adapters: The adapters are comprised of short pieces of tubing in a "Y" configuration primarily to adapt a single tube cuff to a dual tube hose or a dual tube cuff to a single tube hose as required by the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm or leg
Indicated Patient Age Range
adult, pediatric, infant and neonatal
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)
The Advantage Cuffs were tested according to the applicable sections of the following standards:
AAMI SP-10:2002 & 2002/A1:2003 Manual, electronic or automated Sphygmomanometers
BS EN 1060 Non-Invasive Sphygmomanometers
ISO 10993 Biological Evaluation of Medical 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.
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
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Advantage Medical Electronics, Inc. The text "ADVANTAGE MEDICAL" is in large, bold, black letters. Below this, the text "Electronics, Inc." is in smaller, lighter letters.
510(K) SUMMARY
MAR 2 0 2007
KOS3863
113
Submitter Information
- Advantage Medical Cables, Inc. Name: 10630 Wiles Road Coral Springs, Florida 33076 USA
- Phone: 954-345-9800 Fax: 954-345-0507 Web: www.advantagemed.com
- Contact: Ken Kendricks Extension 1012 kenk@advantagemed.com
Date prepared: December 18, 2006
Name of Device
- Trade Name: Advantage Cuff NIBP Hose NIBP Adapter
- Common Name: Non-invasive Blood Pressure Cuff NIBP Hose NIBP Adapter
- Classification Name: Cuff, Blood Pressure, DXQ, 870.1120 Class II Device NIBP Hoses and Adapters are not classified. Classified same as BP cuff by default.
Legally marketed predicated device
AMC has identified a legally marketed predicated device of substantial equivalence to the Advantage Cuff, NIBP Hose and Adapter.
Sensa®-Cuff, produced by GE® Medical Systems, 510(k) K022482. See Attachment 1.
1
KOG38G3 p.213
GE® Medical Systems Hose "Spare Parts".
GE® Medical Systems, Critikon® Adapters, REF: 330084.
No 510(k) numbers are listed for hoses and adapters.
Description
The Advantage Cuff, NIBP Hose and Adapters are accessories for noninvasive blood pressure systems.
Cuff: The cuff is comprised of an air tight bladder enclosed in an inelastic sleeve with one or two tubes and the appropriate connectors for the type device required. The Advantage Cuffs come in a range of sizes, each marked with the appropriate limb circumference for which the cuff is intended.
Hose: The hose is comprised of single or dual tubing, in various lengths as required by the customer or application, with the appropriate connectors attached to each end of the tubing.
Adapters: The adapters are comprised of short pieces of tubing in a "Y" configuration primarily to adapt a single tube cuff to a dual tube hose or a dual tube cuff to a single tube hose as required by the customer. 1
Intended Use
The Advantage Cuff is an accessory that is intended to be used with manual or automated noninvasive sphygmomanometers. The cuff makes no diagnosis. The cuffs are provided non-sterile and may be reused. The cuff is not designed, sold or intended for use except as indicated.
The NIBP Hose and Adapters are accessories that are intended to be used with manual or automated noninvasive sphygmomanometers. They make no diagnosis. The hoses and adapters are provided non-sterile and may be reused. The hose and adapters are not designed, sold or intended for use except as indicated.
Comparison of Predicated Devices
The Advantage Cuffs, NIBP Hoses and Adapters have the same basic construction as the predicated devices. Both devices are wrapped the patients arm or leg and secured by a hook and loop fastener commonly called Velcro. Both devices are available in the same size and range and are intended for the same patient populations.
Testing
2
The Advantage Cuffs were tested according to the applicable sections of the following standards:
AAMI SP-10:2002 & 2002/A1:2003 Manual, electronic or automated Sphygmomanometers BS EN 1060 Non-Invasive Sphygmomanometers ISO 10993 Biological Evaluation of Medical Devices
Conclusion
The Advantage Cuff is equivalent in safety and usage to the legally marketed predicated devices.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2007
Advantage Medical Cables, Inc. c/o Mr. Kenneth E. Kendricks Vice President 10630 Wiles Road Coral Springs, Florida 33076
Re: K063863
Trade Name: Advantage Cuff, NIBP Hose, and NIBP Adapter Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: December 22, 2006 Received: December 28, 2006
Dear Mr. Kendricks:
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.
4
Page 2 - Mr. Kenneth E. Kendricks
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,
Bhimima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 -
Indications for Use
510(k) Number (if known): K063863 Device Name: Advantage Cuff, NIBP Hose and NIBP Adapter Indications For Use:
AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIBP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummina
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