(151 days)
Not Found
No
The device description and intended use clearly define a simple mechanical accessory (blood pressure cuff) with no mention of computational or analytical capabilities, let alone AI/ML. The mention of "AI" in the standard "ANSI/AAMI SPIO, Manual, electronic or automated sphygmomanometers, 2002+AI.:2003+A2:2006+(R)2008" refers to an amendment or addendum to the standard, not artificial intelligence within the device itself.
No.
The device is described as an accessory for blood pressure measurement systems to measure the patient's blood pressure, not to treat a medical condition.
No
The device is an accessory used to measure blood pressure, which provides data for a diagnosis, but it does not diagnose conditions itself.
No
The device description clearly states it comprises physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook and loop closure, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that the blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is wrapped around a patient's limb to measure blood pressure directly on the patient.
- Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient.
Therefore, based on the provided information, the GH blood pressure cuff is a medical device used for direct physiological measurement on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- GH Reusable Blood Pressure Cuff: "The GH 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated."
- GH Disposable Blood Pressure Cuff: "The GH 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."
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
"Both devices comprise 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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's limb (arm or leg)
Indicated Patient Age Range
Neonatal, pediatric 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)
The new devices were designed and manufactured in accordance with the following standards:
- ANSI/AAMI SPIO, Manual, electronic or automated sphygmomanometers, 2002+AI.: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- PartS5: 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
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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2014
Shanghai GaoHui Rubber and Plastic Company c/o Ms. Rhonda Thompson Alexander Registrar Corp. 144 Research Drive Hampton, VA 23666
Re: K140874
Trade/Device Name: GH Disposable and GH Reusable Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II Product Code: DXQ Dated: July 23, 2014 Received: July 24, 2014
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.
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
1
Page 2 - Ms. Rhonda Thompson Alexander
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140874
Device Name GH Reusable Blood Pressure Cuff
The GH 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 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Indications for Use
510(k) Number (if known) K140874
Device Name
GH Disposable Blood Pressure Cuff
Indications for Use (Describe)
The GH 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: | Shanghai GaoHui Rubber and Plastic Company |
| Address: | No 381, Hong An Road, Xinnong Zhujing Zhen |
| Jinshan District, China 201503 | |
| Telephone: | +86 21 54360656 |
| Fax Number: | +86 21 54357084 |
| Contact Person: | Richard Gao, Vice General Manager |
| Date Prepared: | February 12, 2014 |
B. Device
| Trade Name: | GH Disposable Blood Pressure Cuff
GH Reusable Blood Pressure Cuff |
|--------------------|----------------------------------------------------------------------|
| Common Name: | Blood Pressure Cuff |
| Product Code: | DXQ |
| Class: | Class 2 |
| Regulation Number: | 21 CFR 870.1120 |
C. Identification of Legally Marketed Predicate Device
| Name: | Non-Invasive Blood Pressure Cuff |
|---|---|
| Manufacture: | Caremate Medical Device Co., Ltd. |
| K Number: | K102792 |
| Name: | Non-Invasive Blood Pressure Cuff |
| Manufacture: | Unimed Medical Supplies Inc. |
| K Number: | K112544 |
D. Description of the Device
Both devices comprise 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.
E. Intended Use
The GH disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for
5
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 GH 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
| Features | Shanghai GaoHui Rubber and
Plastic Company | Caremate Medical Device Co.,
Ltd. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | GH Disposable Blood Pressure Cuff | Non-invasive Blood Pressure Cuff |
| Intended use | The GH 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. | Indirect measurement of blood
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 sizes
recommendations | Conform to AHA bladder sizes
recommendations |
| | Neonate 1 (3-6) | Neonate 1 (3.3-5.6) |
| | Neonate 2 (4-7) | Neonate 2 (4.2-7.1) |
| | Neonate 3 (5-11) | Neonate 3 (5-10.5) |
| | Neonate 4 (7-12) | Neonate 4 (6.9-11.7) |
| | Neonate 5 (9-15) | Neonate 5 (8.9-15) |
| | Neonate 6 (8-12) | Neonate 6 (7.7-10.5) |
| | Neonate 7 (10-14) | Neonate 7 (9.8-13.3) |
| | Neonate 8 (12-17) | Neonate 8 (12.4-16.8) |
| | Infant 9(16-22) | Infant 9(15.8-21.3) |
| | Child 10(20-27) | Child 10(20-27) |
| | Small adult 11(26-35) | Small adult 11(25.3-34.3) |
| | Adult 12 (32-43) | Adult 12 (32.1-43.4) |
| | Thigh 13 (46-66) | Thigh 13 (46-66) |
| Sterility | Not supplied sterile | Not supplied sterile |
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993
biocompatibility evaluation | Comply with ISO 10993
biocompatibility evaluation |
F. Comparison to the Predicate Device
6
The GH Disposable Blood Pressure Cuff has the same Intended 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. 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.
| Features | Shanghai GaoHui Rubber and Plastic Company
GH Reusable Blood Pressure Cuff | Unimed Medical Supplies Inc.
K112544
Non-invasive Blood Pressure -Cuff |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| Indications for use | The GH 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive 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 | Adults/Pediatrics |
| Tube Configuration | One or two tube | One or two tube |
| Size (range in cm) | Conform to AHA bladder sizes recommendations
Neonate 1 (3-6)
Neonate 2 (4-7)
Neonate 3 (5-11)
Neonate 4 (7-12)
Neonate 5 (9-15)
Neonate 6 (8-12)
Neonate 7 (10-14)
Neonate 8 (12-17)
Infant 9(16-22)
Child 10(20-27)
Small adult 11(26-35)
Adult 12 (32-43)
Thigh 13 (46-66) | Conform to AHA bladder sizes recommendations
Neonatal (6-11)
Infant (10-19)
Pediatric(16-26)
Small adult(20-28)
Adult (25-35)
Large Adult (33-47)
Thigh (46-66) |
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| Repeated inflation | 10,000 inflations | 10,000 inflations |
|---|---|---|
| 3,000 hook and loop closures | 3,000 hook and loop closures | |
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993 | Comply with ISO 10993 |
| biocompatibility evaluation | biocompatibility evaluation | |
| Material of cuff | Cuff : woven nylon. | |
| light and soft, Nontoxic, anti bacterial | Cuff: Pu Synthetic Leather | |
| light and soft, Nontoxic, anti bacterial | ||
| Material of tube | PVC : stable ; corrosion resistance ; | |
| heat-resistance | PVC : stable ; corrosion resistance ; | |
| heat-resistance | ||
| Material of Bladder | TPU : stable ; corrosion resistance ; | TPU : stable ; corrosion resistance ; |
| Material of | ||
| hook&loop fastener | Nylon: stable,corrosion resistance ; | |
| heat-resistance , anti pollution,fast | ||
| colors | Nylon:stable,corrosion resistance ; | |
| heat-resistance , anti pollution,fast | ||
| colors |
G. Summary of Testing
Both new devices were designed and manufactured in accordance with the following standards:
- . ANSI/AAMI SPIO, Manual, electronic or automated sphygmomanometers, 2002+AI.: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- PartS5: 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
H. Conclusion of Substantial Equivalence
Based on the comparison of intended use, design, materials and performance, we conclude that the new devices are substantially equivalent to the predicates. The differences between the devices do not raise new questions of safety and effectiveness.