(82 days)
The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
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.
The provided document describes a medical device, the Unimed Blood Pressure Cuff, and its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML-based device, nor details about acceptance criteria or a study proving its performance in the context of an AI/ML system.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample sizes, data provenance, number of experts, adjudication method (for an AI/ML device)
- MRMC comparative effectiveness study or standalone performance (for an AI/ML device)
- Type of ground truth, training set sample size, and ground truth establishment (for an AI/ML device)
The document focuses on demonstrating the bio-compatibility and physical performance characteristics of a traditional blood pressure cuff through compliance with established standards (ANSI/AAMI SP10, ISO 10993).
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Image /page/0/Picture/1 description: The image shows a logo with the words "Med" on top of "Uni". The logo is contained within a black box with rounded corners. The text is white, and the background of the box is black.
Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26828795 Fax: 86 755 26697984 Email: info@unimed.cn Website: www.unimed.cn
Section 3
510(K) Summary
Summary prepared Date: April 2, 2011
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: info@unimed.cn, tanxinmei1979@163.com
Device Name
Trade Name: Unimed Blood Pressure Cuff Common Name: Non-invasive Blood pressure cuff Product Code/Classification: DXQ/21 CFR870.1120 Review Panel: Cardiovascular
Predicate Device
Sensa-Cuff (K022482) GE Medical Systems Information Technologies
Intended Use
The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive
Confidential
Unimed Blood Pressure Cuff - 510(k) Submission
Page 1 of 4
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Image /page/1/Picture/0 description: The image is a logo for MedUni. The logo is in a rectangular shape with rounded corners. The text "Med" is on the top line, and the text "Uni" is on the bottom line. There is a horizontal line separating the two lines of text.
Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26828795 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in 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 | GE Medical |
|---|---|---|
| Intended use | Indirect measurement ofblood pressure | Indirect measurement ofblood pressure |
| Patient Populations | Adults/Pediatrics | Adults/Pediatrics |
| Material | Cuff: PU Synthetic LeatherBladder: TransparentPolyurethane (TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon | Cuff: Woven nylonFilm (bladder): Ethylene vinylacetate copolymer (EVA)Tubing: PVCRibbon: Textured polyesterHook: Molded NylonLoop: Nylon |
| Tube Configuration | One or two tube | One or two tube |
| Size(Range in cm) | Conform to AHA bladder sizesrecommendationsNeonatal (6-11cm)Infant (10-19cm) | Conform to AHA bladder sizesrecommendationsInfant (8-13cm)Child (12-19cm) |
Comparison to the Predicate Device
Confidential
UnImed Blood Pressure Cuff - 510(k) Submission
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Image /page/2/Picture/0 description: The image shows a logo with the text "Med Uni" in a bold, sans-serif font. The text is arranged in two lines, with "Med" on the top line and "Uni" on the bottom line. The logo is enclosed in a rounded rectangle with a thick black border. The background of the logo is white, while the text is black.
Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26828795 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
| Pediatric (18-26cm) | Small Adult (17-25) | |
|---|---|---|
| Small Adult (20-28cm) | Adult (23-33cm) | |
| Adult (25-35cm) | Large Adult (31-40cm) | |
| Adult Long (25-35cm) | Thigh (38-50cm) | |
| Large Adult (33-47cm) | ||
| Large Adult Long (33-47cm) | ||
| Adult Thigh (46-66cm) | ||
| Repeated inflation | 10,000 inflations | 10,000 inflations |
| 3,000 hook and loop closures | 3,000 hook and loop closures | |
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993 | Comply with ISO 10993 |
| biocompatibility evaluation | biocompatibility evaluation |
The Unimed 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.
(1) Material: Although the patient materials for subject device and predicate device are not all the same, but they are all conformed to ISO 10993.
(2) Size: We extend the length of the cuffs in order to accommodate special groups, such as neonates and 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.
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Image /page/3/Picture/0 description: The image shows a logo with the words "Med Uni" stacked on top of each other. The logo is enclosed in a rounded rectangle with a thick black border. There is a horizontal line separating the two words. The text is in a bold, sans-serif font.
Medical Supplies Inc. Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26828795 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
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, 2003
- � 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
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Unimed Medical Supplies, Inc. c/o Mr. Clare He Underwriters Laboratories Inc. Electronic Building, Parage Electronic Industrial Park No. 8 Nanyun Er Road, Gangzhou 510663 CHINA
NOV 22 2011
Re: K112544
Trade/Device Name: Unimed Blood Pressure Cuffs: U1883S, U1883D, U1882S, U1882D, U1881S, U1881D, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, U1869S, U1869D, U1889S, U1889D, U1884S, and U1884D (18 models) Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXO Dated: November 4, 2011 Received: November 8, 2011
Dear Mr. He:
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 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. Clare He
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
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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Image /page/6/Picture/0 description: The image is a logo for Med Uni. The logo is in a rounded rectangle shape. The words "Med" and "Uni" are stacked on top of each other in the center of the logo.
Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26828795 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Section 4 Indications for Use Statement
510(k) Number:
KII2544
Device Name: Unimed Blood Pressure Cuff
Indications for Use
The Unimed Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR
/OR
Over-The-Counter Use _
(Part 21 CFR 801 Sub part D)
(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)
Signature
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510(k) Number K112544
Confidential
Unimed Blood Pressure Cuff - 510(k) Submission
Page 1 of 1
§ 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).