(88 days)
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.
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 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.
Here's the breakdown of the acceptance criteria and the study that demonstrates the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the Unimed Disposable Blood Pressure Cuff was tested according to relevant standards to demonstrate its performance. The key acceptance criteria are derived from these standards and the comparison to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | Indirect measurement of blood pressure; non-sterile and for single-patient use; available in neonatal, pediatric, and adult sizes. |
| Patient Populations Supported | Adults/Pediatrics |
| Tube Configuration | One or two tubes |
| Size (Range in cm) - Conformity to AHA Bladder Sizes | 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). Note: States conformance to AHA recommendations. |
| Sterility | Not supplied sterile (Non-sterile). |
| Pressure Limits | 0-300mmHg |
| Biocompatibility | Complies with ISO 10993 biocompatibility evaluation (ISO 10993-1, ISO 10993-5, ISO 10993-10). |
| Basic Construction & Technology | Same as predicate device (inelastic sleeve with integrated inflatable bladder, hook and loop closure). |
| Safety and Effectiveness | No safety or effectiveness issues identified based on performance testing and comparison to predicate. |
2. Sample Sizes and Data Provenance:
The document does not explicitly state the sample sizes used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "performance testing in this submission" but does not provide details on the number of subjects or the type of study conducted.
3. Number of Experts and Qualifications for Ground Truth:
This information is not provided in the document. The performance testing appears to be based on compliance with established medical device standards and comparison to a predicate device, rather than a study requiring expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication Method:
Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. This type of method is not applicable to the performance testing described for the Unimed Disposable Blood Pressure Cuff, which focuses on physical and biological properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This device is a blood pressure cuff, an accessory for non-invasive blood pressure measurement, not an AI-powered diagnostic tool requiring human reader performance analysis. Therefore, the effect size of human readers improving with or without AI assistance is not relevant or reported.
6. Standalone Performance Study:
A standalone performance study focused on the device's technical specifications and compliance with standards was conducted. The document states: "The Unimed Blood Pressure Cuff has been tested according to the following standards:" and lists ANSI/AAMI SP10 and ISO 10993 series. These tests evaluate the device's inherent performance characteristics independently.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is based on established medical device standards and regulatory requirements. Specifically:
- ANSI/AAMI SP10: This standard sets requirements for manual, electronic, and automated sphygmomanometers, which would include accuracy and performance criteria for the cuff component.
- ISO 10993 series: These standards establish the framework for biological evaluation of medical devices to ensure biocompatibility.
- Comparison to the predicate device (JOHNSON & JOHNSON MEDICAL, INC. Soft-Cuff K974080): The predicate device serves as a benchmark for demonstrating substantial equivalence in terms of intended use, basic construction, technology, and performance.
8. Sample Size for the Training Set:
This concept is not applicable here. The Unimed Disposable Blood Pressure Cuff is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" for this type of device, this question is not applicable. The device's performance is assessed against established engineering and biological safety standards.
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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
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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 & JOHNSONMEDICAL (GE Healthcare) |
|---|---|---|
| Intended use | Indirect measurement ofblood pressure | Indirect measurement ofblood 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 sizesrecommendationsNeonate 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 sizesrecommendationsNeonatal 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
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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 10993biocompatibility evaluation | Comply with ISO 10993biocompatibility 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
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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.
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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.
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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
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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 |
§ 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).