(58 days)
Not Found
No
The device is a simple physical barrier (a cuff cover) and the description focuses on its material composition and function in preventing cross-contamination. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No.
The device acts as a barrier to prevent cross-contamination, not to treat, diagnose, cure, or mitigate a disease or condition.
No
This device is a barrier used to prevent cross-contamination for blood pressure cuffs. It does not measure, diagnose, or monitor any bodily functions or conditions.
No
The device description clearly states it is a physical cover made of paper and polyethylene, designed to be placed between a patient's arm and a blood pressure cuff. It is a tangible, physical barrier, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a physical barrier designed to prevent cross-contamination between a patient's arm and a blood pressure cuff. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use is to reduce or prevent cross-contamination during blood pressure measurement, not to diagnose or monitor a medical condition through the analysis of biological samples.
- Device Description: The description clearly outlines a physical barrier made of paper and polyethylene, applied externally to the patient's arm. There is no mention of reagents, assays, or any components used for analyzing biological samples.
Therefore, this device falls under the category of a medical device, but specifically not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
Product codes
DXQ
Device Description
This device is a cover for blood pressure cuffs. It is made of soft medical grade paper with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff barrier can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff barrier has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff barrier has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff barrier is a single use product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff barrier.
The blood cuff barrier has a two layer structure. The inner layer that has immediate contact with patient skin is made of soft medical grade paper. The outer layer that has immediate contact underneath the blood pressure cuff is made of cast film of polyethylene.
The whole barrier is approximately 20 um thick and is available in various different length and width. The barrier can be secured around the patient arm by two sided adhesive tape with removable liner. The adhesive tape and liner are located at the end of outer layer and do not contact the patient skin.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was performed per ISO 10993-1, and internal procedures to ensure that the SAMA Disposable Blood Pressure Cuff Barriers met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Key Metrics
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/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three wavy lines representing the hair or head. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Pinghu Sama Medical Packing Co., Ltd. % Mr. Charles Shen Regulatory Correspondent MANTON BUSINESS AND TECHNOLOGY SERVICES 853 Dorchester Ln. Unit-b New Milford, New Jersey 07646
Re: K141998
Trade/Device Name: SAMA Disposable Blood Pressure Cuff Barriers Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: July 23, 2014 Received: July 25, 2014
Dear Mr. Charles Shen,
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
1
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 devicerelated 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 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" (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 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 vours.
Muke Jellman
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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K141998 Page 1 of 1
Section 4: Indications for Use
510(k) Number (if known): N/A
Device Name: SAMA Disposable Blood Pressure Cuff Barriers
Indications for Use:
This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
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510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Pinghu Sama Medical Packing Co., Ltd. 1 Qunfeng Road, South of Lindai Pinghu, Zhejiang Province, China 314202 Tel: (086) 573-85923333 Submitter's FDA Registration Number: N/A
5.2 Contact Person
Charles Shen Manton Business and Technology Services 853 Dorchester LN, Unit-B New Milford, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: July 15, 2014
5.4 Device Name:
| Proprietary Name: | SAMA Disposable Blood Pressure Cuff Barriers |
|---|---|
| Common Name: | Blood Pressure Cuff Cover |
| Classification Name: | Blood Pressure Cuff |
| Device Classification: | II |
| Regulation Number: | 21 CFR 870.1120 |
| Panel: General | Cardiovascular |
| Product Code: | DXQ |
ર્સ્ટ Predicate Device Information:
- K031195, "Cuf-Cover", manufactured by "Ethox Corp", Located in Buffalo, NY, (1) USA
5.6 Device description:
This device is a cover for blood pressure cuffs. It is made of soft medical grade paper with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs
4
are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff barrier can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff barrier has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff barrier has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff barrier is a single use product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff barrier.
The blood cuff barrier has a two layer structure. The inner layer that has immediate contact with patient skin is made of soft medical grade paper. The outer layer that has immediate contact underneath the blood pressure cuff is made of cast film of polyethylene.
The whole barrier is approximately 20 um thick and is available in various different length and width. The barrier can be secured around the patient arm by two sided adhesive tape with removable liner. The adhesive tape and liner are located at the end of outer layer and do not contact the patient skin.
5.7 Intended Use:
This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
5.8 Summary of Device Testing:
Bench testing was performed per ISO 10993-1, and internal procedures to ensure that the SAMA Disposable Blood Pressure Cuff Barriers met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
5.9 Safety and Effectiveness
It has been shown in this 510(k) submission that SAMA Disposable Blood Pressure Cuff Barriers and its predicate devices have very similar indications for use, design, composition, biocompatibility, and performance.
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The difference between the SAMA Disposable Blood Pressure Cuff Barriers and their predicate device do not raise any question regarding its safety and effectiveness.
SAMA Disposable Blood Pressure Cuff Barriers, as designed and manufactured, are as safe and effective as its predicate device, and therefore is substantially equivalent as its predicate device.