(88 days)
Not Found
No
The description is for a standard blood pressure cuff, an accessory to a blood pressure measurement system, with no mention of AI/ML capabilities or related performance metrics/studies.
No
The device is described as an accessory used for non-invasive blood pressure measurement, which is a diagnostic function, not a therapeutic one.
No
The device is described as an accessory (blood pressure cuff) used to measure blood pressure, not to diagnose a condition. It facilitates a measurement which can be used in diagnosis, but is not diagnostic itself.
No
The device description clearly outlines physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook and loop closure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory used in conjunction with noninvasive blood pressure measurement systems. This is a physiological measurement taken directly from the patient's body.
- Device Description: The description details a physical cuff and tubing used to apply pressure to a limb. This is a mechanical component for a physical measurement.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVD devices are specifically designed for testing samples in vitro (in glass or in a lab setting).
- Performance Standards: The listed performance standards (ANSI/AAMI SP10, ISO 10993) are related to blood pressure measurement and biological compatibility with the body, not to the analysis of biological samples.
Therefore, the Unimed disposable blood pressure cuff is a medical device used for a physiological measurement in vivo (within the living body), not an IVD.
N/A
Intended Use / Indications for Use
The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Product codes
DXQ
Device Description
The device comprises tubing attached to an 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 a non-invasive blood pressure measurement system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb (arm or leg)
Indicated Patient Age Range
neonatal, pediatric and adult
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 Unimed Blood Pressure Cuff has been tested according to the following standards:
- ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009
- ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1:2006
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
K120364 MAY - 4 2012
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/0/Picture/3 description: The image shows the logo for Unimed medical supplies. The logo consists of the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a circular graphic with the letters "UM" inside. The logo is simple and modern, and it is likely used to identify the company and its products.
Section 3
510(K) Summary
Summary prepared Date: January 12, 2012
Submitter Information:
Unimed Medical supplies Inc.
No.37, Yanshan Road, Shekou, Shenzhen, China 518067
Contact Person:
Xinmei Tan, QA manager No.37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: (86) 755 26695165 Fax: (86) 755 26697984 Email: tanxinmei@unimed.cn; caijiye@unimed.cn
Device Name
Trade Name: Unimed Disposable Blood Pressure Cuff Common Name: Non-invasive Blood pressure cuff Product Code/Classification: DXQ/21 CFR870.1120 Review Panel: Cardiovascular
Predicate Device
Soft-Cuff (K974080) JOHNSON & JOHNSON MEDICAL, INC. (GE Healthcare)
Intended Use
The Unimed disposable blood pressure cuff is an accessory used in conjunction with
Confidential
1
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/1/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo consists of the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a stylized oval shape containing the letters "UM".
noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Device Description
The device comprises tubing attached to an 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 a non-invasive blood pressure measurement system.
| Features | Unimed Medical | JOHNSON & JOHNSON
MEDICAL (GE Healthcare) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Indirect measurement of
blood pressure | Indirect measurement of
blood pressure |
| Patient Populations | Adults/Pediatrics | Adults/Pediatrics |
| Tube Configuration | One or two tube | One or two tube |
| Size
(Range in cm) | Conform to AHA bladder sizes
recommendations
Neonate 1 (3-6)
Neonate 2 (4-8)
Neonate 3 (6-11)
Neonate 4 (7-13)
Neonate 5 (8-15)
Infant (9-14.8)
Child (13.8-21.5)
Small Adult (20.5-28.5)
Adult (27.5-36.5)
Adult Long(27.5-36.5)
Large Adult (35.5-46cm)
Large Adult Long(35.5-46cm)
Thigh (45-56cm) | Conform to AHA bladder sizes
recommendations
Neonatal 1 (3-6)
Neonatal 2 (4-8)
Neonatal 3 (6-11)
Neonatal 4 (7-13)
Neonatal 5 (8-15)
Infant (8-13)
Child (12-19)
Small Adult (17-25)
Adult (23-33)
Large Adult (31-40)
Thigh (38-50) |
Comparison to the Predicate Device
2
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/2/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo consists of the word "UNIMED" in bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "UNIMED" is a circular graphic with the letters "UM" inside.
| Sterility | Not supplied sterile | Not supplied sterile |
|---|---|---|
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993 | |
| biocompatibility evaluation | Comply with ISO 10993 | |
| biocompatibility evaluation |
The Unimed Disposable Blood Pressure Cuff has the same Intended Use, basic construction, and technology specification as the predicated devices are wrapped the patient's 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. The materials of both devices are all conformed to ISO 10993. We extend the length of the cuffs in order to accommodate special groups, such as overweight subjects. Based on the performance testing in this submission, the slight difference on the range of these blood pressure cuffs does not raise any safety or effectiveness issue.
Performance Summary
The Unimed Blood Pressure Cuff has been tested according to the following standards:
- � ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and � testing within a risk management process, 2009
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for � irritation and delayed-type hypersensitivity, 2002+A1:2006
3
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Conclusion
The subject device Unimed Blood Pressure Cuff has all features of the predicate
device. The few differences do not affect the safety and effectiveness of the
subject devices.
Thus, the subject device is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a circle of text around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The caduceus is depicted with a single snake winding around a staff, and the overall design is simple and clean.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 4 2012
Unimed Medical Supplies, Inc. Xinmei Tan Quality Assurance Manager No.37, Yanshan Road, Shekou, Shenshen 518067 China
K120364 Re:
Trade/Device Name: Unimed Blood Pressure Cuffs: U1710S, U1720S, U1730S, U1740S, U1750S, U1760S, U1770S, U1790S, U1710D, U1720D, U1730D, U1740D, U1750D, U1760D, U1770D, U1790D, U1781S, U1782S, U1783S, U1784S, U1785S, U1781D, U1782D, U1783D, U1784D, U1785D Regulation Number: 21 CFR 870.1120
Regulation Name: Blood Pressure Cuff
Regulatory Class: Class II (two)
Product Code: DXO
Dated: February 2, 2012
Received: February 6, 2012
Dear Mr. Tan:
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.
5
Page 2 - Mr. Xinmei Tan
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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/6/Picture/1 description: The image shows the logo for Unimed Medical Supplies. The word "Unimed" is in bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a black circle with a white "UM" inside.
Section 4 Indications for use Statement
510(k) Number: _
Device Name: Unimed Disposable Blood Pressure Cuff
Indications for Use
The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Prescription Use __ X_ (Part 21 CFR 801 Sub part D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K120364 |