(102 days)
Not Found
No
The device description and performance studies focus on the physical components and standard performance testing of a disposable blood pressure cuff, with no mention of AI or ML technologies.
No
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems. It directly facilitates the measurement process rather than providing therapeutic treatment itself.
No
Explanation: The device is a blood pressure cuff, which is an accessory to a blood pressure measurement system. It does not perform diagnostic functions itself but rather facilitates the measurement process.
No
The device description explicitly states it contains a "Cuff with bladder and Air Hose" and is made of "non-woven fabrics & PVC (Cuff) and PVC (Air Hose)", indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is applied externally to the patient's limb to facilitate the measurement of blood pressure. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for use with noninvasive blood pressure measurement systems, which are external measurement devices.
- Device Description: The description focuses on the physical components of the cuff and its application to the patient's limb. There is no mention of analyzing biological samples.
Therefore, the disposable blood pressure cuff falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DXQ
Device Description
The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.
The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff 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 device is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonate, infant, child and adult sizes.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
The biocompatibility evaluation for the Disposable Blood Pressure Cuffs was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Cytotoxicity Sensitization Irritation
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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November 21, 2022
Wenzhou Xikang Medical Instruments Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K222420
Trade/Device Name: Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: October 25, 2022 Received: October 25, 2022
Dear Boyle 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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222420
Device Name Disposable Blood Pressure Cuff
Indications for Use (Describe)
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child 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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Wenzhou Xikang Medical Instruments Co., Ltd. |
|---|---|
| Address: | No. 1478 Haining Road, Haibin Street, Longwan District |
| Wenzhou, Zhejiang 325024, China | |
| Tel: | +86-577-86876969 |
| Contact: | Wang Tiance |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date Submitted: Aug.4th,2022
2.0 Device Information
| Trade/Device name: | Disposable Blood Pressure Cuff |
|---|---|
| Common name: | Non-invasive blood pressure cuff |
| Classification name: | Blood Pressure Cuff |
| Classification Product Code: | DXQ |
| Regulation number: | 870.1120 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
Predicate Device:
| Manufacturer: | Shenzhen Caremed Medical Technology Co., Ltd. |
|---|---|
| Trade/Device Name: | Caremed Reusable Blood Pressure Cuff, Caremed |
| Disposable Blood Pressure Cuff |
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510(k) number: K182433
4.0 Device Description
The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.
The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff 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 device is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
5.0 Indication for Use Statement
The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
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6.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device | Comparison
Analysis |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Product Name | Disposable Blood
Pressure Cuff | Caremed Disposable
Blood Pressure Cuff | ---- |
| 510(k) No. | Pending | K182433 | ---- |
| Product Code | DXQ | DXQ | Same |
| Regulation No. | 21 CFR 870.1120 | 21 CFR 870.1120 | Same |
| Class | II | II | Same |
| Intended
Use/Indication
for Use | The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | 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 cuff is not designed, sold, or intended for use except as indicated.
The 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | Same with the
Indication for
Use of the
Disposable
Blood Pressure
Cuff |
| Material
Composition | Cuff (Patient contacted): PVC film
stick non-woven fabric;
Bladder:PVC
Air Hose:PVC
Hook tape: Nylon
Loop: Nylon | Non-woven (Patient contacted);
nylon;
PVC | Same |
| Patient
Populations | Adults/Pediatrics | Adults/Pediatrics | Same |
| Tube Number | One or two | One or two | Same |
| Limb
Circumference
(Range in cm) | Conform to AHA bladder sizes
recommendations | Conform to AHA bladder sizes
recommendations | |
| | Neonatal 1 (3-6 cm) | Neonatal 1 (3-6 cm) | Different |
| | Neonatal 2 (4-8 cm) | Neonatal 2 (4-8 cm) | |
| | Neonatal 3 (6-11 cm) | Neonatal 3 (6-11 cm) | |
| | Neonatal 4 (7-13 cm) | Neonatal 4 (7-13 cm) | |
| | Neonatal 5 (8-15 cm) | Neonatal 5 (8-15 cm) | |
| | Infant (9-15 cm) | Infant (9-14.8 cm) | |
| | Child (13-20 cm) | Child (13.8-21.5 cm) | |
| | Small Adult (18-26 cm) | Small Adult (20.5-28.5 cm) | |
| | Adult (25-35 cm) | Adult (27.5-36.5 cm) | |
| | Large Adult (32-42 cm) | Adult Long (27.5-36.5/46.5 cm) | |
| | Thigh (42-50 cm) | Large Adult (35.5-46 cm) | |
| | | Large Adult Long (35.5-46 cm) | |
| Pressure Range | 0-300mmHg | 0-300mmHg | Same |
| Max. Pressure | 400mmHg | 400mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibility | Conform with ISO10993-1
(ISO10993-5, ISO10993-10) | No potential cytotoxicity;
No sensitization observed (test sample score 0);
Negligible (no observed primary irritation, test sample score 0) | Same |
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The Subject Device has the same Intended Use/Indication for Use, basic construction, and technology specification as the predicated device. Both devices are wrapped the patient's arm or leg and secured by a hook and loop fastener commonly called Velcro. The materials of both devices are all conformed to ISO 10993. Both devices are available in the similar size and range and are intended for the same patient populations, and the size for Infant, Child, Small Adult and Large Adult are little different. 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.
7.0 Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for
7
Irritation and Skin Sensitization.
Biocompatibility testing
The biocompatibility evaluation for the Disposable Blood Pressure Cuffs was conducted in accordance with the FDA Biocompatibility guidance, 2016 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process") and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Cytotoxicity Sensitization Irritation
8.0 _Summary of Clinical Testing
No clinical study is included in this submission.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K182433 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.