(154 days)
K08085, K062238
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a blood pressure cuff, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is used to determine blood parameters by wrapping on the upper arm with a non-invasive blood pressure monitor, which is a diagnostic function, not a therapeutic one.
No
The device, a blood pressure cuff, collects blood pressure parameters but requires a separate non-invasive blood pressure monitor system to determine "blood parameters." It does not independently diagnose conditions based on this information.
No
The device description clearly describes a physical, inelastic sleeve (cuff) with tubes and a bladder, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine blood parameters on neonate, pediatric and adult patients" by being "wrapped on the upper arm and used with a non-invasive blood pressure monitor system." This describes a device used externally on the body to measure a physiological parameter (blood pressure), not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a physical cuff that inflates and deflates to measure blood pressure. This aligns with a non-invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVDs.
Therefore, the Blood Pressure Cuff described is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
Product codes
DXQ
Device Description
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
neonate, pediatric and adult patients
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)
The device was tested per ISO 10993 series standards to evaluate its biocompatibility and AAMI SP10:2002+A1:2003+A2:2006.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K08085, K062238
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
| Attachment II 510(k) Summary | ||||
|---|---|---|---|---|
| A required by 21 CFR 807.92 | ||||
| The assigned 510(k) number is: _ K102825 | ||||
| Date of Preparation | September 28, 2010 | |||
| 510(k) Sponsor | APK Technology Co., Ltd, Registration #: 3007699081 | |||
| 504, C6 Building, Hengfeng Industry, Hezhou, | ||||
| Xixiang, Baoan District, Shenzhen, Guangdong, 518126, China | ||||
| Contact Person: Cindy Chan | ||||
| Tel: 86-755-27325581 | ||||
| Fax: 86-755-27325585 | ||||
| Email: cindy@apk-technology.com | ||||
| Submission | Mr. Lee Fu | |||
| Correspondent | Mid-Link Consulting Co., Ltd | |||
| P.O. BOX 237-023, Shanghai, 200237, China | ||||
| T: +86-21-22815850 F: 240-238-7587 | ||||
| Proposed Device | Device Trade Name: Blood Pressure Cuff; | |||
| Classification: Class II DXQ 21 CFR 870.1120; | ||||
| Intended Use | Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped | |||
| on the upper arm and used with a non-invasive blood pressure monitor system to | ||||
| determine blood parameters on neonate, pediatric and adult patients. |
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Additional Information I for K102825 Blood Pressure Cuff -Attachment II 510(k) Summary
Device Description
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.
| Model | Intended Arm Range (Unit: cm) | Disposable | Reusable |
|---|---|---|---|
| A-XT-12D(1) | 3.3-5.6 | X | |
| A-XT-12D(2) | 4.2-7.1 | X | |
| A-XT-12D(3) | 5-10.5 | X | |
| A-XT-12D(4) | 6.9-11.7 | X | |
| A-XT-12D(5) | 8.9-15 | X | |
| A-XT-12D(7) | 9.8-13.3 | X | |
| A-XT-09D(8) | 12.4-16.8 | X | |
| A-XT-08D(9) | 15.8-21.3 | X | |
| A-XT-08D(10) | 20-27 | X | |
| A-XT-07D(11) | 25.3-34.3 | X | |
| A-XT-10D(12) | 32.1-43.4 | X | |
| A-XT-11D(13) | 44-66 | X | |
| A-XT-07 | 25-35 | X | |
| A-XT-08 | 18-26 | X | |
| A-XT-09 | 10-19 | X | |
| A-XT-10 | 33-47 | X | |
| A-XT-11 | 44-66 | X | |
| A-XT-12 | 6-11 | X | |
| A-XT-12W(1) | 3.3-5.6 | X | |
| A-XT-12W(2) | 4.2-7.1 | X | |
| A-XT-12W(3) | 5-10.5 | X | |
| A-XT-12W(4) | 6.9-11.7 | X | |
| A-XT-12W(5) | 8.9-15 | X | |
| A-XT-12W(7) | 9.8-13.3 | X | |
| A-XT-09W(8) | 12.4-16.8 | X | |
| A-XT-08W(9) | 15.8-21.3 | X | |
| A-XT-08W(10) | 20-27 | X | |
| A-XT-07W(11) | 25.3-34.3 | X | |
| A-XT-10W(12) | 32.1-43.4 | X | |
| A-XT-11W(13) | 44-66 | X |
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Additional Information I for K102825 Blood Pressure Cuff -Attachment II 510(k) Summary
The device was tested per ISO 10993 series standards to evaluate its Testing Summary biocompatibility and AAMI SP10:2002+A1:2003+A2:2006. The proposed devices, Blood Pressure Cuff, are claimed to be Substantially SE Conclusion Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff, K08085 and Tytan Blood Pressure Cuff, K062238.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APK Technology Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA
MAR - 2 2011
Re: K102825
Trade/Device Name: Disposable Blood Pressure Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: January 25, 2011 Received: January 28, 2011
Dear Ms. Hong:
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 - Ms. Diana Hong
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/ReportalProblem/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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Additional Information I for K102825 Blood Pressure Cuff -- Attachment I Indication for Use Statement
Attachment I Indication for Use Statement
510(k) Number: K102825 Device Name: Blood Pressure Cuff
Indications for Use:
Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Len for BZuckerman
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