The Hygia Health Services Reprocessed Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual or automatic sphygmomanometers as appropriate. The device is non-sterile and is intended as a single patient use device. It is available in neonatal through large adult size.

The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.

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 Hygia Health Services Reprocessed Blood Pressure 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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a reprocessed blood pressure cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details about a study designed to meet specific performance criteria using AI, are not present.

However, based on the information provided, here's a breakdown of what can be extracted and inferred regarding performance and testing:

1. A table of acceptance criteria and the reported device performance:

Since this is a reprocessed device seeking substantial equivalence, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices. The performance reported centers on demonstrating that the reprocessed device matches these characteristics.

Acceptance Criterion (Implicitly, from predicate devices)	Reported Device Performance (Hygia Reprocessed BP Cuff)
Functional and operational performance characteristics (compression, pressure control, leakage)	"functional and operational performance characteristics including compression, pressure control, leakage... were substantially equivalent."
Safety parameters	"safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent."
Operational parameters when connected to inflation and measurement equipment	"safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent."
Design, materials, energy source, mode of operation	"The technological characteristics... are identical to the originally manufactured Blood Pressure Cuff in design, materials, energy source, mode of operation, and performance characteristics."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," but does not provide details on the number of cuffs or tests performed.
Data Provenance: Not explicitly stated. The testing was "Non-clinical Tests" and conducted by Hygia Health Services, Inc. within the USA. It appears to be prospective testing specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. The ground truth for this device's performance is not established by expert consensus on clinical findings. Instead, it's established by comparing physical and functional characteristics to new, predicate devices.
Qualifications of Experts: N/A.

4. Adjudication method for the test set:

Adjudication Method: Not applicable in the context of expert review. The "adjudication" was a comparison of physical and functional test results against established specifications or performance of predicate devices.

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:

MRMC Study: No.
Effect Size: Not applicable. This document is for a physical medical device (blood pressure cuff), not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Study: Not applicable. This device is a blood pressure cuff and does not involve an algorithm or AI.

7. The type of ground truth used:

Ground Truth: The "ground truth" for this reprocessed device is effectively the published specifications and demonstrated functional performance of the new, un-reprocessed predicate blood pressure cuffs. The study aimed to show that the reprocessed cuff performs identically or substantially equivalently. The "test conclusions" explicitly state: "Non-clinical test results...indicated substantial equivalence in the measured characteristics to the predicate devices, the as originally manufactured blood pressure cuffs."

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable, as there is no training set.

Summary

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DEC - 5 2003

E. 510(k) Summary of Safety and Effectiveness

Submitter:	Hygia Health Services, Inc.
	434 Industrial Lane
	Birmingham, Alabama 35211
Date:	June 21, 2003

1.	Contact Person	Ms. Tracy Comas
		Chief Operating Officer
		Tel: 205-314-3920
		Fax: 205-314-3959

2. Name of Device

Classification Name:	Cuff, Blood Pressure CFR 870.1120
Common or Usual Name:	Blood Pressure Cuff
Review Panel:	Cardiovascular
Classification:	Class II
Product Code	DXQ
Proprietary Name:	Hygia Health Services Reprocessed Blood PressureCuff

3. Predicate Devices

Device	Manufacturer	510(k)
Critikon Soft BloodPressure Cuff	Johnson and Johnson	K974080
Disposa-Cuff® bloodpressure cuff	Crest Medical Equipment	K790810
Surgi-Cuff®	Ethox Corporation	K883977
CUFF-ABLE® Cuff	Vital Signs, Inc.(Bio-Medical Dynamics)	K911213
Statcorp Disposable BloodPressure Cuff	Statcorp, Incorporated	K940214
Technicuff®	TECHNICUFF CORP.	K942259
Cloud Cuff®	Parts Port, Ltd	K002360

4. Device Description

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5. Intended Use

6. Technological Characteristics

The technological characteristics of the Hygia Health Services Reprocessed Blood Pressure Cuff are identical to the originally manufactured Blood Pressure Cuff in design, materials, energy source, mode of operation, and performance characteristics. Some of the original devices are indicated for multiple patient usage whereas the Hygia Health Services reprocessed devices are indicated for single patient use only. The only differences between the original devices and the reprocessed devices are with respect to changes that result from the cleaning, disinfection, repackaging and relabeling processes used by Hygia Health Services to prepare the used original devices for safe and effective use on other patients as a single usage device.

7. Performance Data

Non-clinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed Blood Pressure Cuff and the predicate devices. 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 were substantially equivalent.

Test Conclusions- Non-clinical test results of the Hygia Health Services Reprocessed Blood Pressure Cuff indicated substantial equivalence in the measured characteristics to the predicate devices, the as originally manufactured blood pressure cuffs.

8. Statement of Substantial Equivalence

The Hygia Health Services Reprocessed Blood Pressure 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 may be marked for "single-patient use only" or for "multiple uses". After reprocessing, they are marked for "single patient use" only. Hygia Health Services does not change the device in any way except to return the device to a "usable" condition by processing it through a scientifically validated disinfection procedure. The Hygia Health Services high level disinfection (HLD) protocol does not alter the efficacy, safety, composition, or intended use of the device. The basis of operation for the devices is the inflation of a bladder, which is placed around the patient's limb. The cuff is connected to a compatible inflation device. Inflation of the device may be accomplished either manually or automatically according to the type of instrument used.

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1. Hygia Reprocessed BP Cuffs

Manufacturer

Allegiance Healthcare Welch Allyn Johnson & Johnson Kimberly-Clark Corporation Spacelab Medical Kimberly Clark Corporation Vital Signs Technicuff Medline

Product

Tactics Soft Blood Pressure Cuff Soft Blood Pressure Cuff Critikon Soft Cuff Soft and Vinyl Personal Cuff Tru-cuff vinyl and soft Novaplus soft disposables Cuffable BP Cuff BP Cuff Soft and Vinyl

Note: Welch Allyn manufacturers and private labels BP cuffs for Allegiance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Hygia Health Services c/o Mr. Tracy Wood Comas Chief Operating Officer 434 Industrial Lane Birmingham, Alabama 35211

Re: K032821

Trade Name: Reprocessed Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: NPP Dated: November 24, 2003 Received: November 25, 2003

Dear Mr. Comas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 commerce pror to that 2011-17-11 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). and Cosmotion (100 (110) that the device, subject to the general controls provisions of the Act. The I ou may, attress, sizions 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. Tracy Wood Comas

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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Megan Mayer

). Zuckerman, M.D. Hram Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the word "HYGIA" in a bold, serif typeface. To the left of the word is a black square containing three concentric white circles. The circles are not complete, but rather are arcs that suggest a sphere or globe. The overall impression is one of a logo or brand mark.

Hygia Health Services 434 Industrial Lane Birmingham, AL 35211 1-866-943-6670

Contents: Reprocessed and Repacked Medical Device Original Equipment Manufacturer (OEM): Critikon

OEM Catalog #: 2363

Hygia Catalog #: IIIIS-2363

Product Description: Soft-CufTM Adult Cuff Size 23-33cm

For Single Patient Use Only Non-Sterile, Latex Free

Caution: Federal Law restricts this device to sale by or on order of a physician.

Instructions for Use:

1. Place cuff under upper arm of patient.
Fold side of cuff with dashed index line over patient's arm. 2.
1. Fold Velcro® side of cuff over dashed index side. Secure Velcro® attachment.
1. Insure that the tube is directed down away from the cuff.
న్. Insure that the cuff is securely attached to the patient.
1. Inflate cuff.

Indications:

Cautions:

l. Proper cuff application is essential.
Cuff should be removed immediately if the patient experiences tingling, numbness, or pain. The 2. physician should be notified.
Cuff should not be used over an open wound, gangrene, untreated infected wound, recent skin 3. grafts, or dermatitis.
র্ব . Cuff should not be inflated too tightly so as not to occlude circulation.
న్న If inflated too loosely, the cuff will not deliver maximum benefits.

Contraindications:

The Hygia Reprocessed Blood Pressure Cuff should NOT be used in the following conditions: 1. Any local condition in which the garment would interfere:

. open wounds
untreated infected wounds ●
gangrene ●
recent skin graft
dermatitis

CMe st Map
n-om

ber K032821

Prescription Use J1 (Part 21 CFR 801 Suppart D)

AND/OR

Over-The-Counter Use X
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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).