(277 days)
Not Found
No
The device description and intended use are for a simple, disposable blood pressure cuff, which is a mechanical accessory. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML. The performance testing is based on a standard for blood pressure cuffs, not on algorithmic performance.
No
The device is described as an accessory used in conjunction with noninvasive blood pressure measurement systems, indicating it aids in diagnosis/monitoring rather than direct treatment or therapy.
No
The device is a blood pressure cuff, which is an accessory used with blood pressure measurement systems, not a diagnostic device itself. It collects data for diagnosis but does not perform the diagnosis.
No
The device description clearly states it is a physical blood pressure cuff, a hardware component, and does not mention any software functionality.
Based on the provided information, the Med-link Disposable Blood Pressure Cuff 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.
- 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 facilitate the measurement of blood pressure in vivo (within the living body).
- No Sample Analysis: The device does not involve the collection or analysis of any biological samples.
Therefore, the Med-link Disposable Blood Pressure Cuff falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Med-link 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
The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb/thigh
Indicated Patient Age Range
neonatal, pediatric and adult
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)
A series of safety, essential performance and in vitro biocompatibility tests were performed to assess the safety and effectiveness of Med-link Disposable Blood Pressure Cuff.
The tests listed below were conducted in accordance with
ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing
Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ISO 10993-5
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for Irritation And Skin Sensitization
ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type
- Cytotoxicity Test .
- Skin irritation Test
- . Skin Sensitization Test (the Guinea Pig maximization test )
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard.
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.
Public Health Service
November 28, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Med-link Electronics Tech Co., Ltd. Mina Cheng Regulatory Affairs Specialist 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen, 518109 CN
Re: K160530
Trade/Device Name: Med-link Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 22, 2015 Received: February 25, 2016
Dear Mina Cheng:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (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 yours.
Mude Jellm
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) K160530
Device Name Med-link Disposable Blood Pressure Cuff
Indications for Use (Describe)
Med-link 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) |
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Image /page/3/Picture/0 description: The image shows the logo for MedLinket. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of "MED" is a red circle, followed by the word "LINKET" in blue, with a "TM" symbol in the upper right corner.
Shenzhen Med-link Electronics Tech Co., Ltd.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR§807.92. Type of submission: Traditional The assigned 510(k) number is:K160530
1. Submitter information
Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th Fl, Bldg A, Yingtailong Industrial Park, Dalang South Road, Longhua District, Shenzhen, Guangdong, CHINA, 518109 Tel: 0086-755-61120299 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961
2. Contact Person
Mina Cheng (Regulatory Affairs Specialist) E-mail: user22@med-linket.com
3. Date of preparation
Nov. 19, 2016
4. I Identification of the Device
Trade Name: Med-link Disposable Blood Pressure Cuff
Models as listed below:
| Device Name/Type | Device Model |
|---|---|
| Disposable Blood | |
| Pressure Cuff | Y000DSN1-1#, Y000DSN2-1#, Y000DSN1-2#, Y000DSN2-2#, |
| Y000DSN1-3#, Y000DSN2-3#, Y000DSN1-4#, Y000DSN2-4#, | |
| Y000DSN1-5#, Y000DSN2-5#, Y000DC1, Y000DC2, Y000DSA1, | |
| Y000DSA2, Y000DA1, Y000DA2, Y000DAL1, Y000DAL2, | |
| Y000DLA1, Y000DLA2, Y000DT1, Y000DT2 |
Common Name: Non-invasive Blood Pressure Cuff
II
Classification Name: Blood Pressure Cuff
Device Classification:
Classification Regulation: 21 CFR 870.1120
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Image /page/4/Picture/0 description: The image shows the logo for MedLinket. The logo has the word "MED" in red, with the letters stacked on top of each other. There is a blue swoosh underneath the word "MED", and a red circle to the right of the swoosh. The word "LINKET" is in blue, and is to the right of the red circle, with the letters in a bold font. There is a trademark symbol to the right of the word "LINKET".
Product Code: DXQ
5. I Identification of the Predicate Device
| No. | Device Name | Common
Name | Manufacture | Classification
and Code | Classificiation
regulation | 510(k)
number |
|------------------------|--------------------------------------------|----------------------------------------|---------------------------------------------|----------------------------|-------------------------------|------------------|
| Primary
Predicate | Disposable/Reusable
Blood Pressure Cuff | Non-invasive
Blood
pressure cuff | XUZHOU
MAICUFF
TECHNOLOGY
CO.,LTD. | Class II,
DXQ | 21 CRF
870.1120 | K151290 |
| Secondary
Predicate | Unimed Disposable
Blood Pressure Cuff | Non-invasive
Blood
pressure cuff | Unimed Medical
supplies Inc. | Class II,
DXQ | 21 CRF
870.1120 | K120364 |
Table 2 Predicate Devices Information
Intended Use and Indications for Use of the Subject device 6.
Med-link 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.
7. Device Description
The proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.
| No. | Model | Intended Limb Range
(Unit: cm) |
|-----|-------------|-----------------------------------|
| 1 | Y000DSN1-1# | 3 - 6 |
| 2 | Y000DSN2-1# | 3 - 6 |
| 3 | Y000DSN1-2# | 4 - 8 |
| 4 | Y000DSN2-2# | 4 - 8 |
| 5 | Y000DSN1-3# | 6 - 11 |
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Image /page/5/Picture/0 description: The image shows the logo for Medlinket. The logo is red and blue, with the word "MED" in red and the word "LINKET" in blue. There is a red circle in the middle of the logo. The logo also has the trademark symbol.
| Shenzhen Med-link Electronics Tech Co., Ltd. | |||
|---|---|---|---|
| No. | Model | Intended Limb Range
(Unit: cm) |
|-----|-------------|-----------------------------------|
| 6 | Y000DSN2-3# | 6 - 11 |
| 7 | Y000DSN1-4# | 7 - 14 |
| 8 | Y000DSN2-4# | 7 - 14 |
| 9 | Y000DSN1-5# | 8 - 15 |
| 10 | Y000DSN2-5# | 8 - 15 |
| 11 | Y000DC1 | 15 - 22 |
| 12 | Y000DC2 | 15 - 22 |
| 13 | Y000DSA1 | 17 - 25 |
| 14 | Y000DSA2 | 17 - 25 |
| 15 | Y000DA1 | 24 - 32 |
| 16 | Y000DA2 | 24 - 32 |
| 17 | Y000DAL1 | 28 - 37 |
| 18 | Y000DAL2 | 28 - 37 |
| 19 | Y000DLA1 | 32 - 42 |
| 20 | Y000DLA2 | 32 - 42 |
| 21 | Y000DT1 | 42 - 50 |
| 22 | Y000DT2 | 42 - 50 |
Table 4 Contact Components and Relevant Materials
| Device Type | Contact Components | Contact Materials |
|---|---|---|
| Med-link Disposable Blood | ||
| Pressure Cuff | Inner face of hose | Nonwoven Polyester with a |
| PVC laminate Backing |
8. Non-clinical Testing
A series of safety, essential performance and in vitro biocompatibility tests were performed to assess the safety and effectiveness of Med-link Disposable Blood Pressure Cuff.
The tests listed below were conducted in accordance with
ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing
Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ISO 10993-5
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for Irritation And Skin Sensitization
ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type
6
Image /page/6/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word "LINKET".
- Cytotoxicity Test .
- Skin irritation Test
- . Skin Sensitization Test (the Guinea Pig maximization test )
9. Technological Comparison with Predicate Device
| Item | Proposed Device | Primary Predicate | Secondary Predicate |
|---|---|---|---|
| Trade name | Med-link Disposable Blood | ||
| Pressure Cuff | Disposable Blood Pressure | ||
| Cuff | Unimed Disposable Blood | ||
| Pressure Cuff | |||
| 510(K) | |||
| Submitter | Shenzhen Med-link | ||
| Electronics Tech Co., Ltd. | XUZHOU MAICUFF | ||
| TECHNOLOGY CO.,LTD. | Unimed Medical supplies Inc. | ||
| 510(K) Number | — | K151290 | K120364 |
| Classification | |||
| Regulation | 21CRF 870.1120 | 21CRF 870.1120 | 21CRF 870.1120 |
| Classification | |||
| and Code | Class II, | ||
| DXQ | Class II, | ||
| DXQ | Class II, | ||
| DXQ | |||
| Common name | Non-invasive Blood Pressure | ||
| Cuff | Non-invasive Blood Pressure | ||
| Cuff | Non-invasive Blood Pressure | ||
| Cuff | |||
| Intended use | Med-link 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. | 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 neonatal, | |||
| pediatric and adult sizes. | The Unimed 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. | |||
| Patient | |||
| populations | Adults/Pediatrics | Adults/Pediatrics | Adults/Pediatrics |
| Tube | |||
| configuration | One or two tube | One or two tube | One or two tube |
| Size | Conform to AHA bladder | Conform to AHA bladder | Conform to AHA |
| bladder | |||
| Item | Proposed Device | Primary Predicate | Secondary Predicate |
| sizes recommendations | sizes recommendations | sizes recommendations | |
| Neonatal 1# (3-6cm) | Neonatal 1 (3-5.5 cm) | Neonate 1 (3-6 cm) | |
| Neonatal 2# (4-8cm) | Neonatal 2 (4-8 cm) | Neonate 2 (4-8 cm) | |
| Neonatal 3# (6-11cm) | Neonatal 3 (6-11 cm) | Neonate 3 (6-11 cm) | |
| Neonatal 4# (7-14cm) | Neonatal 4 (7-13 cm) | Neonate 4 (7-13 cm) | |
| Infant (8-15cm) | Infant (9-14.5 cm) | Neonate 5 (8-15 cm) | |
| Pediatric (15-22 cm) | Pediatric (13-21.5 cm) | Infant (9-14.8 cm) | |
| Small Adult (17-25 cm) | Small Adult (21-27 cm) | Child (13.8-21 cm) | |
| Adult (24-32cm) | Adult (26-35.5 cm) | Small Adult (20.5-28.5 cm) | |
| Adult long(28-37cm) | Adult (27.5-36.5 cm) | ||
| Large Adult (32-42cm) | Large Adult(35-45 cm) | Large Adult (35.5-46 cm) | |
| Thigh (42-50cm) | Large Adult Long | ||
| (35.5-46cm) | |||
| Thigh (45-56cm) | |||
| Pressure limit | 0-300mmHg | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| AAMI/ANSI/ISO81060-1:20 | |||
| Non-clinical | |||
| Requirement | 07/(R)2013 | ||
| Comply with ISO 10993 | |||
| biocompatibility evaluation | Comply with ISO 10993 | ||
| biocompatibility evaluation | Comply with ISO | ||
| 10993 | |||
| biocompatibility evaluation | |||
Table 4 Comparison to Primary Predicate Device
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Image /page/7/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the swoosh is a red circle, followed by the word "LINKET" in blue. There is a small "TM" symbol in the upper right corner of the word "LINKET".
Shenzhen Med-link Electronics Tech Co., Ltd.
Med-link Disposable Blood Pressure Cuff has the same intended use, basic construction and technology specification as the predicate device. They are wrapped around the patient's arm or thigh and secured by a hook and loop fastener commonly called Velcro.
We extend the size to satisfy some special patients such as different neonatal size. 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.
10. Comparison of Performance with Predicate Device
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard.
11. Conclusion
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Image /page/8/Picture/0 description: The image shows the logo for Medlinket. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the swoosh is a red circle, and then the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word LINKET.
Shenzhen Med-link Electronics Tech Co., Ltd.
After analyzing safety, essential performance and biocompatibility testing data, it can be concluded that: Med-link Disposable Blood Pressure Cuff are safe and effective as the predicate device.