(10 days)
Not Found
No
The description focuses solely on the physical components and function of a standard blood pressure cuff, with no mention of AI or ML.
No
The device is intended for determining a person's blood pressure, which is a diagnostic measurement, not a therapeutic intervention.
No
The device is a blood pressure cuff, which is an accessory used in conjunction with a blood pressure monitoring system. It does not independently diagnose.
No
The device description clearly outlines a physical blood pressure cuff with an inflatable bladder, tubing, and connectors, which are hardware components.
Based on the provided information, the Devon AccuBP Cuff is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens, including blood, urine, and tissue, taken from the human body to help diagnose diseases or conditions.
- Devon AccuBP Cuff Function: The description clearly states the device is a blood pressure cuff used in conjunction with a non-invasive blood pressure monitoring system to determine a person's blood pressure. This is a non-invasive measurement taken directly from the patient's limb, not from a specimen taken from the body.
- Intended Use: The intended use is for determining blood pressure, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the Devon AccuBP Cuff falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant and adult sizes.
Product codes
DXQ
Device Description
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Devon AccuBP Cuffs are Latex Free.
The Devon AccuBP Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
Attached to the end of each PVC tube are a variety of connectors for use with most monitoring systems.
The AccuBP Cuffs are available in the following configurations:
Five sizes for Neonatal (Neonatal #1-#5) and eight sizes for (Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh)
Both Single Tube and Double Tube configuration are available for all size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
neonatal, infant and adult sizes
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 and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Devon AccuBP Cuff. Tests showed that the functional and operational performance characteristics including compression, pressure control, leakage, and both safety and operational parameters used when connected to inflation and measurement equipment meet standard ANSI/AAMI SP-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 1: 510(k) Summary
MAR 2 3 2009
Submitter:
Devon Medical Inc. 1100 15t Ave, Suite 100 King of Prussia, PA 19406
Contact Person:
Ruth Wu, COO (Official Correspondent) Address: 1100 First Avenue, Suite 100 · King of Prussia, PA 19406, USA 800.571.3135 Phone: 484.636.3380 Fax:
Common Classification & Proprietary Names:
| Common Names: | Blood Pressure Cuff |
|---|---|
| Proprietary Name: | AccuBP Cuff |
Date Prepared:
February 18th 2009
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the AccuBP Cuff.
| Classification Name | 21 CFR Section | Product Code | Class |
|---|---|---|---|
| Blood Pressure Cuff | 870.1120 | DXQ | II |
Predicate Devices
The AccuBP Cuff is substantially equivalent to the following:
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| Medline Single Patient Use Blood Pressure Cuff | Medline Industries, Inc. | K071244 |
The AccuBP Cuff has the same intended use and general construction as the predicate devices and is available in the same sizes of Statcorp Disposable Blood Pressure Cuff and has the same functional performance with Statcorp Disposable Blood Pressure Cuff.
Device Description
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Devon AccuBP Cuffs are Latex Free.
The Devon AccuBP Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure
1
measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
Attached to the end of each PVC tube are a variety of connectors for use with most monitoring systems.
The AccuBP Cuffs are available in the following configurations:
Five sizes for Neonatal (Neonatal #1-#5) and eight sizes for (Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh)
Both Single Tube and Double Tube configuration are available for all size.
Intended Use
The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant and adult sizes.
Technological Characteristics
The Devon AccuBP Cuff are identical to the Medline Single Patient Use Blood Pressure Cuff in design, mode of operation, and performance characteristics, all of these cuffs are configured for use with a wide variety of manual and automated sphygmomanometers.
Performance
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Devon AccuBP Cuff. Tests showed that the functional and operational performance characteristics including compression, pressure control, leakage, and both safety and operational parameters used when connected to inflation and measurement equipment meet standard ANSI/AAMI SP-10.
Statement of Substantial Equivalence
The AccuBP Cuff is substantially equivalent in technology, function, operating parameters, and intended use to Blood Pressure Cuffs that are currently commercially available and in distribution. The original devices are marked for "single-patient use only".
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, concludes that the AccuBP Cuff, is safe and effective and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
MAR 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Devon Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K090664
Devon AccuBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXO Dated: March 11, 2009 Received: March 13, 2009
Dear Mr. Job:
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
Page 2 - Mr. Mark Job
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 elcctronic 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,
ina R. bahnes
Image /page/3/Picture/5 description: The image shows a symbol that appears to be a stylized or abstract design. It features curved lines and loops, creating a flowing and somewhat calligraphic appearance. The symbol is simple and lacks any shading or color variations, suggesting it may be a logo, icon, or signature.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: The Devon AccuBP Cuff
Indications for Use:
The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, through adult sizes.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sime D. Vochme
(Division, S Division . I ardiovascula
2090664 5 Tu(K) Numbe
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