(15 days)
Not Found
Not Found
No
The document describes a standard blood pressure cuff accessory and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an accessory used in conjunction with noninvasive blood measurement systems. A blood pressure cuff measures a physiological parameter (blood pressure) and does not treat or cure a disease or condition, which are characteristics of a therapeutic device.
No
The Sensa-Cuff Blood Pressure Cuff is described as an accessory used in conjunction with blood pressure measurement systems. It is a cuff that wraps around a limb and connects to a measurement system, implying it's a component for obtaining a measurement, not a device that itself diagnoses. Its intended use is to facilitate noninvasive blood pressure measurement, not to interpret data or make a diagnosis.
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.
Based on the provided information, the Sensa-Cuff Blood Pressure Cuff is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory used with noninvasive blood measurement systems. This involves measuring a physiological parameter (blood pressure) directly from the patient's body.
- Device Description: The description details a physical device that is applied externally to the patient's limb.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sensa-Cuff does not interact with or analyze such specimens.
Therefore, the Sensa-Cuff Blood Pressure Cuff falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood 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.
Product codes
DXQ-870.1120, DXQ
Device Description
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. 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
Not Found
Indicated Patient Age Range
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 Sensa-Cuff Blood Pressure Cuffs were tested according to the applicable sections of the following standards:
- SP-9 Nonautomated Sphygmomanometer
- BS EN 1060 Non-Invasive Sphygmomanometers
- ISO 10993 Biological Evaluation of Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DURA-CUF®-Preamendment Critikon Company, LLC
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).
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The letters are black, and the circle is also black with white accents around the edges.
AUG 1 3 2002
GE Medical Systems Information Technologies
General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000
SUMMARY OF SAFETY AND EFFECTIVENESS June 24, 2002
Sensa-Cuff
A. Submitter
GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614
B. Company Contact
Primary: Melissa Robinson, Regulatory Affairs Specialist Phone: 813-887-2133 Fax: 813-887-2552
Secondary:
Tom English, Global QA/RA Phone: 813-887-2107 Fax: 813-887-2413
C. Device Name
Trade Name: Common Name: Classification/Product Code: Sensa-Cuff Blood Pressure Cuff DXQ-870.1120
D. Predicate/Legally Marketed Devices
DURA-CUF®-Preamendment Critikon Company, LLC
E. Device Description
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.
F. Intended Use
The Sensa-Cuff 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 pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Page 1 of 2
Image /page/0/Picture/23 description: The image shows a sequence of digits, specifically "00007". The digits are printed in a bold, sans-serif font, and they appear to be slightly distressed or aged, giving them a textured look. The digits are evenly spaced and aligned horizontally.
1
-
G. Testing
The Sensa-Cuff Blood Pressure Cuffs were tested according to the applicable sections of the following standards: -
•SP-9 Nonautomated Sphygmomanometer
-
•BS EN 1060 Non-Invasive Sphygmomanometers
-
•ISO 10993 Biological Evaluation of Medical Devices
H. Comparison to the Predicate Device
| COMPARISON OF THE Critikon Sensa-Cuff to the Critikon DURA-CUF® | ||
|---|---|---|
| Features | DURA-CUF® | Sensa-CUFF |
| Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| Patient Populations | Adults/pediatrics | Adults/pediatrics |
| Material | Cuff Substrate: Polyurethane | |
| coated nylon woven cloth | ||
| Tubing: SE-BS Thermoplastic | ||
| elastomer | ||
| Hook: Molded Nylon | ||
| Loop: Nylon | Cuff material: Woven nylon | |
| Film (bladder): Ethylene vinyl | ||
| acetate copolymer (EVA) | ||
| Tubing: PVC | ||
| Ribbon: Textured polyester | ||
| Hook: Molded Nylon | ||
| Loop: nylon | ||
| Tube Configuration | 1 and 2 tube | 1 and 2 tube |
| Sizes | ||
| (Ranges in cm) | Conform to AHA bladder size | |
| recommendations | ||
| • Infant (8-13) | ||
| • Child (12-19) | ||
| • Small Adult (17-25) | ||
| • Adult (23-33) | ||
| • Large Adult (31-40) | ||
| • Thigh (38-50) | Conform to AHA bladder size | |
| recommendations | ||
| • Infant (8-13) | ||
| • Child (12-19) | ||
| • Small Adult (17-25) | ||
| • Adult (23-33) | ||
| • Large Adult (31-40) | ||
| • Thigh (38-50) | ||
| Repeated Inflations | 10,000 inflations | |
| 3,000 hook and loop closures | 10,000 inflations | |
| 3,000 hook and loop closures |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
GE Medical Systems Information Technologies c/o Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995
Re: K022482
Trade Name: Sensa-Cuff Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 26, 2002 Received: July 29, 2002
Dear Mr. Rongero:
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. Jeff D. Rongero
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Elisa Diaz for
Bram D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
June 24, 2002
Page 1 of 1
510(K) Number (if known): _ K 022482
Device Name: Sensa-Cuff Blood Pressure Cuff
Indications for Use:
The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood 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.
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
or
Over-The Counter Use
Olish for Bru Zuchn
(Division Sign-Off)
Division of Cardiovascular
8/14/02
nd Respiratory De
510(k) Number
(Optional Format 1-2-96)