(137 days)
The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. 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, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.
This document is solely a 510(k) premarket notification summary for a medical device (Minhua Disposable Blood Pressure Cuff). It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.
The provided text describes a traditional medical device (blood pressure cuff) and focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of Features: Intended use, patient populations, tube configuration, sterility, pressure limits, biocompatibility, cuff and tube port materials, hook & loop fastener, and conformity to AHA bladder sizes.
- Compliance with Standards: ANSI/AAMI SP 10 (sphygmomanometers) and ISO 10993 (biocompatibility).
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it pertains to the evaluation of AI/ML devices, which is not the subject of this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, line-art style.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 15, 2015
Suzhou Minhua Medical Apparatus Supplies Co., Ltd. c/o Rhonda Alexander, Senior Regulatory Specialist Registrar Corp. Medical Device Division 144 Research Drive Hampton, Virginia 23666
Re: K143728
Trade/Device Name: Minhua Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: March 24, 2015 Received: March 25, 2015
Dear Ms. Alexander:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 - Rhonda Alexander
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kenneth J. Cavanaugh -S
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Minhua Disposable Blood Pressure Cuff
Indications for Use (Describe)
The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows a logo for MINHUA. The logo is in blue and features a stylized font. There is a red dot above the letter 'i' in MINHUA. The logo has a modern and clean design.
Suzhou Minhua Medical Apparatus Supplies Co .,LTD Tel: +0086-13601885073 fax:+0086-021-59841086 Email:QD@minhuayiliao.com
510(k) SUMMARY (21 CFR 807.92)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
The assigned 510(k) number is:
Premarket Notification [510(k)] Summary
A. General Information
| Submitter's Name: | Suzhou Minhua Medical Apparatus Supplies Co., LTD |
|---|---|
| Address: | You Yi Industrial park, Songlin Town, |
| WuJiang ,CHINA 215222 | |
| Telephone: | +86 21 59840221-8003 |
| Fax Number: | +86 21 59841086 |
| Contact Person: | Ji Dong Yang, Vice General Manager |
| E-mail: | QD@minhuayiliao.com |
| Date Prepared: | September. 03, 2014 |
B. Device
| Trade Name: | Minhua Disposable Blood Pressure Cuff |
|---|---|
| Common Name: | Blood Pressure Cuff |
| Product Code: | DXQ |
| Class: | Class 2 |
| Regulation Number: | 21 CFR 870.1120 |
| Review Panel: | Cardiovascular |
C. Identification of Legally Marketed Predicate Device
| Name: | Medline Disposable Blood pressure cuffs |
|---|---|
| Manufacture: | Medline Industries, Inc. |
| K Number: | K071244 |
| Date Cleared: | March 5, 2008 |
D. Description of the Device
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.
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Image /page/4/Picture/1 description: The image shows a logo with the word "MINHUA" in blue, stylized with a unique font. The letters are connected and have a geometric appearance. There is a red dot above the "i" in "MINHUA". The logo has a modern and corporate feel.
Suzhou Minhua Medical Apparatus Supplies Co .,LTD Tel: +0086-13601885073 fax:+0086-021-59841086 Email:QD@minhuayiliao.com
E. Intended Use
Indirect measurement of blood pressure.
F .Indications for use
The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. 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.
G. Various size
| Model | Cuff Size | Arm Range | Bladder Range |
|---|---|---|---|
| 002DC01NJT1 | 100x26mm | 30-60mm | 68x26mm |
| 002DC01NJT2 | 100x26mm | 30-60mm | |
| 002DC02NJT1 | 119x31mm | 40-80mm | 76 x 31mm |
| 002DC02NJT2 | 119x31mm | 40-80mm | |
| 002DC03NJT1 | 146x41mm | 60-110mm | 96 x 41mm |
| 002DC03NJT2 | 146x41mm | 60-110mm | |
| 002DC04NJT1 | 181x48mm | 70-130mm | 123 x 48mm |
| 002DC04NJT2 | 181x48mm | 70-130mm | |
| 002DC05NJT1 | 191x56mm | 80-150mm | 132 x 56mm |
| 002DC05NJT2 | 191x56mm | 80-150mm | |
| 002DC06NJT1 | 195x55mm | 80-140mm | 85 x 55mm |
| 002DC06NJT2 | 195x55mm | 80-140mm | |
| 002DC07NJT1 | 274x83mm | 130-200mm | 135 x 83mm |
| 002DC07NJT2 | 274x83mm | 130-200mm | |
| 002DC09NJT1 | 335x107mm | 180-260mm | 185 x 107mm |
| 002DC09NJT2 | 335x107mm | 180-260mm | |
| 002DC11NJT1 | 524x143mm | 260-350mm | 265 x 143mm |
| 002DC11NJT2 | 524x143mm | 260-350mm | |
| 002DC13NJT1 | 605x174mm | 320-420mm | 325 x 174mm |
| 002DC13NJT2 | 605x174mm | 320-420mm | |
| 002DC15NJT1 | 745x198mm | 420-500mm | 425 x 198mm |
| 002DC15NJT2 | 745x198mm | 420-500mm |
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Image /page/5/Picture/1 description: The image contains a logo with the word "MINHUA" in blue, stylized with a unique font. The "i" in "MINHUA" is dotted with a red circle. The logo has a modern and corporate feel, with the letters connected by a blue line at the bottom.
Suzhou Minhua Medical Apparatus Supplies Co .,LTD Tel: +0086-13601885073 fax:+0086-021-59841086 Email:QD@minhuayiliao.com
H. Comparison to the Predicate Device
| Features | Su Zhou Minhua Medical Apparatus SuppliesCo., Ltd | Medline Industries, Inc. |
|---|---|---|
| Intended use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| PatientPopulations | Adults/Pediatrics | Adults/Pediatrics |
| TubeConfiguration | One or two tube | One or two tube |
| Sterility | Not supplied sterile | Not supplied sterile |
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Biocompatibility | Comply with ISO 10993 biocompatibility evaluation | Comply with ISO 10993 biocompatibility evaluation |
| cuff | Non-woven fabric, Nontoxic | Non-woven fabric, Nontoxic |
| Tube portconnector | PVC:stable;corrosion resistance;heat-resistance | PVC:stable;corrosion resistance;heat-resistance |
| Hook & loopfastener | Non-woven fabric+Nylon brushed fabric :stable, corrosion resistance; heat-resistance; | Non-woven fabric+Nylon brushed fabric |
| Conform to AHA bladder sizes | ||
| Recommendations | Recommendations | |
| 002DC01NJT1 100x26mm (3-6cm) | MDS 9741 100x26mm (3-6cm) | |
| Neonat al 1 | 002DC01NJT2 100x26mm (3-6cm) | MDS 9751 100x26mm (3-6cm) |
| Neonat al 2 | 002DC02NJT1 119x31mm (4-8cm)002DC02NJT2 119x31mm (4-8cm) | MDS 9742 119x31mm (4-8cm)MDS 9752 119x31mm (4-8cm) |
| Neonat al 3 | 002DC03NJT1 146x41mm (6-11cm)002DC03NJT21 146x41mm (6-11cm) | MDS 9743 146x41mm (6-11cm)MDS 9753 146x41mm (6-11cm) |
| Neonat al 4 | 002DC04NJT1 181x48mm (7-13cm)002DC04NJT2 181x48mm (7-13cm) | MDS 9744 181x48mm (7-13cm)MDS 9754 181x48mm (7-13cm) |
| Neonat al 5 | 002DC05NJT1 191x56mm (8-15cm)002DC05NJT2 191x56mm (8-15cm) | MDS 9745 191x56mm (8-15cm)MDS 9755 191x56mm (8-15cm) |
| 002DC06NJT1 195x55mm (8-14 cm) | MDS 9710 195x55mm (8-14cm) |
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Suzhou Minhua Medical Apparatus Supplies Co .,LTD Tel: +0086-13601885073 fax:+0086-021-59841086 Email:QD@minhuayiliao.com
| Size | Child | 002DC07NJT1 274X83mm (13-20cm) | Child | MDS 9711 274X83mm (13-20cm) |
|---|---|---|---|---|
| 002DC07NJT2 274X83mm (13-20cm) | MDS 9721 274X83mm (13-20cm) | |||
| Small adult | 002DC09NJT1 335x107mm (18-26cm) | Small adult | MDS 9712 335x107mm (18-26cm) | |
| 002DC09NJT2 335x107mm (18-26cm) | MDS 9722 335x107mm (18-26cm) | |||
| Adult | 002DC11NJT1 524X143mm (26-35cm) | Adult | MDS 9713 524X143mm (26-35cm) | |
| 002DC11NJT2 524X143mm (26-35cm) | MDS 9723 524X143mm (26-35cm) | |||
| Big adult | 002DC13NJT1 605x174mm (32-42cm) | Big adult | MDS 9714 605x174mm (32-42cm) | |
| 002DC13NJT2 605x174mm (32-42cm) | MDS 9724 605x174mm (32-42cm) | |||
| Thigh | 002DC15NJT1 745x198mm (42-50cm) | Thigh | MDS 9715 745x198mm (42-50cm) | |
| 002DC15NJT2 745x198mm (42-50cm) | MDS 9725 745x198mm (42-50cm) |
The Minjua 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. As with the predicate, we provide extended sizes of the cuffs in order to accommodate special groups, such as overweight subjects. Based on the performance testing in this submission, the slight difference between these blood pressure cuffs does not raise any safety or effectiveness issue.
I. Summary of testing
The Minhua Disposable Blood Pressure Cuff has been tested according to the following standards: *ANSI/AAMI SP 10, 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 skin
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Image /page/7/Picture/1 description: The image shows a logo for MINHUA. The logo is blue and features a stylized design with the letters "MINHUA" incorporated into the design. There is a red dot above the letter "i" in MINHUA. The logo has a modern and corporate look.
Suzhou Minhua Medical Apparatus Supplies Co .,LTD Tel: +0086-13601885073 fax:+0086-021-59841086 Email:QD@minhuayiliao.com
sensitization :2010
J. Conclusion of Substantial Equivalence
Based on the comparison of intended use, design, materials and performance, we conclude that the new device is substantially equivalent to the predicate. The differences between the devices do not raise new questions of safety and effectiveness.
§ 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).