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.

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.

AI/ML Overview

The provided 510(k) summary for the Devon AccuBP Cuff describes performance testing, but it is not a study that fits the typical criteria for evaluating algorithmic performance as requested in the prompt. This submission is for a medical device (blood pressure cuff) that performs a physical function, not an algorithm that interprets data.

Therefore, many of the requested fields are not applicable (N/A) in this context, as they pertain to the evaluation of machine learning models or diagnostic algorithms.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance for Devon AccuBP Cuff (K090664)

The Devon AccuBP Cuff is a non-invasive blood pressure cuff. The performance evaluation presented is for the physical device itself, ensuring it meets established standards for blood pressure cuffs.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP-10 (Compression)	Meets standard
ANSI/AAMI SP-10 (Pressure Control)	Meets standard
ANSI/AAMI SP-10 (Leakage)	Meets standard
ANSI/AAMI SP-10 (Safety Parameters)	Meets standard
ANSI/AAMI SP-10 (Operational Parameters when connected to inflation and measurement equipment)	Meets standard

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not specified. The document indicates "Bench and laboratory testing," which would imply a number of cuffs were tested, but the exact quantity is not provided.
Data Provenance: N/A as it's physical product testing, not data-driven. The testing would have been conducted in a laboratory setting by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Number of Experts: N/A. Ground truth for physical device testing is established by direct measurement against a known standard or validated equipment by qualified technicians, not through expert human interpretation.
Qualifications of Experts: N/A. Testing would be performed by engineers or technicians skilled in medical device testing and quality control according to the ANSI/AAMI SP-10 standard.

4. Adjudication Method for the Test Set:

Adjudication Method: N/A. Performance is determined by objective physical measurements compared against the quantitative limits set by the ANSI/AAMI SP-10 standard. There is no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done: No. This type of study is relevant for diagnostic imaging or algorithmic interpretation where human readers' performance is being compared or improved with AI assistance. The Devon AccuBP Cuff is a physical medical device, not an AI for interpretation.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: N/A.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Done:

Standalone Performance Done: No. This pertains to algorithmic performance. The cuff itself is a standalone device in that it functions independently (when connected to a monitoring system), but it does not have an "algorithm" in the sense of a machine learning model.

7. Type of Ground Truth Used:

Type of Ground Truth: Established metrics and thresholds defined within the ANSI/AAMI SP-10 standard for blood pressure cuffs. This includes quantitative measurements for compression, pressure control, and leakage, as well as adherence to safety and operational parameters.

8. Sample Size for the Training Set:

Sample Size (Training Set): N/A. This concept applies to machine learning models that are "trained" on data. The manufacturing of a physical device like a blood pressure cuff does not involve a training set in this context. Design and manufacturing might involve iterative testing, but that's different from a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth Established: N/A (as no training set in the algorithmic sense). The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and the requirements of the ANSI/AAMI SP-10 standard.

Summary

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K090664

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

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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

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.

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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.

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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

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510(k) Number (if known):

K070664

Device Name: The Devon AccuBP Cuff

Indications for Use:

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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Regulation Number and Section

§ 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).