(91 days)
No
The device description and performance studies focus solely on the physical characteristics and functional equivalence of a reprocessed blood pressure cuff, with no mention of AI or ML technologies.
No.
The device is described as an accessory for non-invasive blood pressure monitoring and measurement, indicating a diagnostic rather than therapeutic purpose.
Yes
The device aids in gathering physiological information (blood pressure), which is used for diagnostic purposes by being used in conjunction with blood pressure monitoring systems.
No
The device description clearly states it is a physical blood pressure cuff with an inflatable bladder, tubing, and a sleeve, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Hygia Health Services Reprocessed Blood Pressure Cuff is a physical device used externally on a patient's limb to measure blood pressure. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's used "in conjunction with non-invasive blood pressure monitoring systems" and is applied to the "patient's limb." This is a physical measurement, not an in vitro test.
Therefore, the Hygia Health Services Reprocessed Blood Pressure Cuff falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXQ, NPP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb, upper arm of patient
Indicated Patient Age Range
neonatal through large adult
Intended User / Care Setting
personnel properly trained in the use of manual or automatic sphygmomanometers, trained personnel, clinical setting
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974080, K790810, K883977, K911213, K940214, K942259, K002360
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
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 Pressure | |
| Cuff |
3. Predicate Devices
| Device | Manufacturer | 510(k) |
|---|---|---|
| Critikon Soft Blood | ||
| Pressure Cuff | Johnson and Johnson | K974080 |
| Disposa-Cuff® blood | ||
| pressure cuff | Crest Medical Equipment | K790810 |
| Surgi-Cuff® | Ethox Corporation | K883977 |
| CUFF-ABLE® Cuff | Vital Signs, Inc. | |
| (Bio-Medical Dynamics) | K911213 | |
| Statcorp Disposable Blood | ||
| Pressure Cuff | Statcorp, Incorporated | K940214 |
| Technicuff® | TECHNICUFF CORP. | K942259 |
| Cloud Cuff® | Parts Port, Ltd | K002360 |
4. 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.
1
5. Intended Use
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.
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.
2
-
- 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.
3
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.
4
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
5
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:
-
- Place cuff under upper arm of patient.
- Fold side of cuff with dashed index line over patient's arm. 2.
-
- Fold Velcro® side of cuff over dashed index side. Secure Velcro® attachment.
-
- Insure that the tube is directed down away from the cuff.
- న్. Insure that the cuff is securely attached to the patient.
-
- Inflate cuff.
Indications:
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.
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)