(207 days)
Not Found
No
The device description and performance studies focus on the physical components and standard testing of a blood pressure cuff, with no mention of AI or ML technologies.
No.
The device is used for measurement (diagnosis/monitoring) of blood pressure, not for therapy or treatment.
No.
Explanation: The device is a blood pressure cuff, which is a measurement tool, not a diagnostic device itself. It provides parameters (blood pressure) that can be used by a medical professional for diagnosis, but the cuff itself does not interpret or diagnose.
No
The device description clearly outlines physical components (tubing, sleeve, bladder, hook and loop closure) and its function as a disposable blood pressure cuff, which is a hardware component of a blood pressure measurement system.
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 examine these samples outside of the body.
- Device Function: The Disposable Blood Pressure Cuff is a physical device that is applied to the patient's limb to facilitate the measurement of blood pressure. It is part of a system that interacts directly with the patient's body.
- Intended Use: The intended use is to "determine blood pressure parameters on neonate, pediatric and adult patients." This is a physiological measurement taken in vivo (within the living body).
- Device Description: The description details a physical cuff and tubing that are wrapped around a limb. This is a mechanical component for a physiological measurement.
The device is a medical device used for a physiological measurement, not a test performed on a sample taken from the body.
N/A
Intended Use / Indications for Use
The Disposable Blood Pressure Cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.
Product codes
DXQ
Device Description
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
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
The Disposable Blood Pressure Cuff has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.
- · AAMI SP10: 2002
- · IEC 60601-2-30:1999
· Marketing Specification (SunTech document # 98-00162-XX-MS)
Key Metrics
Not Found
Predicate Device(s)
CRITIKON Soft Cuff, K974080
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
Tech Medical®
100085 11
OCT 20 2008
SunTech Medical, Inc. Abbreviated 510(k) Submission Disposable Blood Pressure Cuff 510(k) Summary March 25, 2008
Page 5-2
(1) Submitter information
.
| Name: | SunTech Medical, Inc |
|---|---|
| Address: | 507 Airport Boulevard |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Telephone: | 919.654.2332 |
| FAX: | 919.654.2301 |
| Contact person: | David Gallick (Official Correspondent). |
| Date prepared: | March 25, 2008 |
(2) Name of Device
| Trade Name: | Disposable Blood Pressure Cuff |
|---|---|
| Common Name: | Blood Pressure Cuff |
| Classification name: | Blood Pressure Cuff, DXQ 870.1120 |
(3) Legally-marketed predicate devices
Sun Tech Medical has identified the CRITIKON Soft Cuff, K974080, as the predicate device for the Disposable Cuff.
The Disposable Blood Pressure Cuff is substantially equivilent to this device.
1
Page 5-3
SunTech Medical
Disposable blood pressure cuff 510(k)
(4) Description
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers
| Pediatric | |||
|---|---|---|---|
| Size | Range | Available tail length | Artwork Color |
| 1 | 3-6 cm | Normal | Orange |
| 2 | 4-8 cm | Normal | Turquoise |
| 3 | 6-11 cm | Normal | Green |
| 4 | 7-13 cm | Normal | Royal Blue |
| 5 | 8-15 cm | Normal | Burgundy |
| Adult | |||
| Size | Range | Available tail length | Artwork Color |
| Infant | 8-13 cm | Normal | Orange |
| Child | 12-19 cm | Normal and Long | Green |
| Sm Adult | 17-25 cm | Normal and Long | Turquoise |
| Adult | 23-33 cm | Normal and Long | Royal Blue |
| Lg Adult | 31-40 cm | Normal and Long | Burgundy |
| Thigh | 38-50 cm | Normal | Brown |
(5) Intended Use
The Disposable Blood Pressure Cuff is intended to be used with a non- invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.
(6) Comparison to Predicate Devices
The device has the same basic construction as the predicate device. Both devices are wrapped around the patients limb and secured by means of a hook and loop type fastener. The devices are manufactured from the same type of material, are available in the same size/ranges and are intended for the same patient populations.
(7) Testing and Validations
The Disposable Blood Pressure Cuff has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.
- · AAMI SP10: 2002
- · IEC 60601-2-30:1999
· Marketing Specification (SunTech document # 98-00162-XX-MS)
(8) Conclusion
In accordance with the Federal Food. Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SunTech Medical concludes that the Disposable Blood Pressure Cuff is safe, effective and substantially equivalent to the predicate device described herein
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 2008
SunTech Medical, Inc c/o Mr. Chuck Setzer Regulatory Manager 507 Airport Blvd. Suite 117 Morrisville, NC 27560
Re: K080854
SunTech Medical Disposable Pressure Cuff, Model DC100 Regulation Number: 21 CFR 870.1120 Regulation Name: Cuff, Blood Pressure Regulatory Class: Class II (two) Product Code: DXQ Dated: October 9, 2008 Received: October 14, 2008
Dear Mr. Setzer:
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 such 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.
3
Page 2 - Mr. Chuck Setzer
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uma R. bochner
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for use
Ko 80854 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Disposable Cuff
Indications for Use:
The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.
Prescription Use X (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)
R. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K080854
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