(323 days)
Not Found
No
The device description and performance studies focus on the physical components and standard testing of a blood pressure cuff, with no mention of AI or ML.
No
The device is described as an "accessory used in conjunction with noninvasive blood pressure measurement systems" and functions as a "blood pressure cuff." Its purpose is for measurement, not for treating any condition.
No
Explanation: The device is a blood pressure cuff, which is an accessory for noninvasive blood pressure measurement systems. While blood pressure measurement can be part of a diagnostic process, the cuff itself does not perform diagnosis; it only facilitates the measurement of a physiological parameter.
No
The device description explicitly details 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 is to be an accessory for noninvasive blood pressure measurement systems. This is a physical 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.
- 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 to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
- Performance Studies: The performance studies focus on physical and biological compatibility (standards like ISO 81060-1, ISO 10993-5, ISO 10993-10), not on the accuracy or performance of a diagnostic test on a biological sample.
The device is a medical device, specifically an accessory for a non-invasive blood pressure measurement system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The reusable 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 neonate, infant, child and adult sizes.
Product codes
DXO
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. The reusable NIBP cuff has 9 models with different size for different population with different arm size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
neonate, infant, child and adult. Also, Adults/Pediatrics/Infants/Neonates
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)
Clinical test: Clinical testing is not required.
Non-clinical data: The Orantech Reusable NIBP Cuff has been tested according to the following standards:
(1) ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
(2) ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
(3) ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
Key results: The tests were selected to show substantial equivalence between the subject device and the predicate.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2018
Orantech Inc. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square, No. 18, Taizi Road Nanshan District, Shenzhen, P.R. China, 518067
Re: K173197
Trade/Device Name: Reusable NIBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: July 12, 2018 Received: July 18, 2018
Dear Kevin Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S5
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173197
Device Name Reusable NIBP Cuff
Indications for Use (Describe)
The reusable 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 neonate, infant, child and adult sizes.
| 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2017/09/15
Submission sponsor 1.
Name: Orantech Inc.
Address: Zone#A,4F,1st Bld,7th Industrial Zone, Yulv Community, GongMing, Guangming New District, Shenzhen, P.R. China 518106 Contact person: Hsin Xiong Title: General manager E-mail: Yunxi.xiong@orantech.cn Tel: +86-755 23243594
Submission correspondent 2.
Name: Chonconn Medical Device Consulting Co., Ltd. Address: 22A, Haijing Square, No. 18, Taizi Road, Nanshan District, Shenzhen, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Reusable NIBP Cuff |
|---|---|
| Model | BP-10BS, BP-20BS, BP-30BS, BP-40BS, BP-50BS, BP-60BS, |
| BP-70BS, BP-80BS, BP-90BS | |
| Common Name | Non-invasive Blood pressure cuff |
| Regulatory Class | Class II |
| Classification | 21CFR 870.1120 / Blood pressure cuff / DXQ |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
By submission of the Traditional 510(k), Orantech Inc. is requesting clearance for Reusable NIBP Cuff. It is comparable to the following legally marketed system:
-
- Unimed Medical Supplies Inc. Blood Pressure Cuff under K112544.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate.
- Unimed Medical Supplies Inc. Blood Pressure Cuff under K112544.
Device Description 5.
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is
4
Orantech
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 reusable NIBP cuff has 9 models with different size for different population with different arm size.
Intended use & Indication for use 6.
The reusable 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 neonate, infant, child and adult sizes.
| Features | Subject Device | Predicate Device K112544 | ||
|---|---|---|---|---|
| Orantech Reusable NIBP Cuff | Unimed Blood Pressure Cuff | |||
| Intended use | The reusable 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 neonate, infant, | ||||
| child and adult sizes. | 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. | ||||
| Patient | ||||
| Populations | Adults/Pediatrics/Infants/Neonates | Adults/Pediatrics/Infants/Neonates | ||
| Material | Cuff: PU Synthetic Leather | |||
| Bladder: Transparent Polyurethane (TPU | ||||
| Film) | ||||
| Tubing: PVC | ||||
| Hook: Molded Nylon | ||||
| Loop: Nylon | Cuff: PU Synthetic Leather | |||
| Bladder: Transparent Polyurethane | ||||
| (TPU Film) | ||||
| Tubing: PVC | ||||
| Hook: Molded Nylon | ||||
| Loop: Nylon | ||||
| Tube Number | One | One or two | ||
| Limb | ||||
| Circumference | ||||
| (Range in cm) | Conform to AHA bladder sizes | |||
| recommendations | ||||
| Neonatal (6-11cm) | ||||
| Infant (8-13cm) | ||||
| Child (12-19cm) | ||||
| Small Adult (17-25cm) | ||||
| Adult (23-33cm) | ||||
| Adult Extra Long (23-33cm) | ||||
| Large Adult (31-40cm) | ||||
| Large Adult Long (31-40cm) | Conform to AHA bladder sizes | |||
| recommendations | ||||
| Neonatal (6-11cm) | ||||
| Infant (10-19cm) | ||||
| Pediatric (18-26cm) | ||||
| Small Adult (20-28cm) | ||||
| Adult (25-35cm) | ||||
| Adult Long (25-35cm) | ||||
| Large Adult (33-47cm) | ||||
| Large Adult Long (33-47cm) |
Comparison to the Predicate Device 7.
5
| Adult Thigh (38-50cm) | Adult Thigh (46-66cm) | |
|---|---|---|
| Repeated | ||
| inflation | 10,000 inflations | |
| 3,000 hook and loop closures | 10,000 inflations | |
| 3,000 hook and loop closures | ||
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993 biocompatibility evaluation | Comply with ISO 10993 biocompatibility evaluation |
Performance Data 8.
Clinical test:
Clinical testing is not required.
Non-clinical data
The Orantech Reusable NIBP Cuff has been tested according to the following standards:
(1) ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
(2) ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009 (3) ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
The tests were selected to show substantial equivalence between the subject device and the predicate.
9. Conclusion
Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that subject device is substantially equivalent to the predicate device and don't raise any new safety and/or effectiveness issues.