(57 days)
Not Found
No
The device description and intended use are for standard blood pressure cuffs, which are mechanical devices. There is no mention of AI, ML, or any computational processing beyond basic measurement.
No
The device is used for non-invasive blood pressure measurement, not for treating a condition. Its function is diagnostic/monitoring, not therapeutic.
No
Explanation: The device is a blood pressure cuff, which is used for measurement but not for diagnosis. It provides data (blood pressure readings) that a healthcare professional might use as part of a diagnostic process, but the cuff itself does not make a diagnosis.
No
The device description explicitly states the device comprises physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook-and-loop fasteners, which are hardware.
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.
- Device Function: The description clearly states that the Dräger cuffs are used for "automatic non-invasive blood pressure measurement." This is a physical measurement taken directly from the patient's limb, not a test performed on a sample outside the body.
- Intended Use: The intended use is for measuring blood pressure, which is a physiological parameter, not for diagnosing a disease or condition based on a biological sample.
Therefore, the Dräger cuffs fall under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.
Product codes
DXQ
Device Description
The devices comprise 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 fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose.
The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.
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
adults, paediatrics, infants and neonates
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022889, K022482, K974080, K991525
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
092999
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional.
510(k) Summary acc. to 21 CFR 807.92
Applicants Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
NOV 2 4 2009
Manufacturer Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number :
9611500
Contact Person:
Ulrich Schröder Director Regulatory Affairs & Clinical Affairs
Tel. No.: 011 49 (451) 882-3648 Fax No.: 011 49 (451) 882-3018
Applicants US Contact Person
Joyce Kilrov Vice President, Processes, Quality & Regulatory
Tel. No.: (215) 660-2626 Fax No.: (215) 721-5424
Date submission was prepared:
2009/09/25
Device Name:
Common Name: Classification Name: Regulation Number: Class:
NBP Cuff / NBP Cuff, Neo blood pressure cuff, DXQ 21 CFR 870.1120 =
1
| 510(k) number | Trade name | Company |
|---|---|---|
| K022889 | Siemens Infinity Modular Monitors, Models | |
| SC 8000, SC 7000 & SC 9000XL & Siemens | ||
| Infinity Explorer | ||
| (cuffs from supplier Statcorp) | Dräger Medical System, Inc | |
| (former Siemens Medical | ||
| Solutions USA, Inc.) | ||
| K022482 | Sensa-Cuf | GE Medical Systems Information |
| Technologies | ||
| K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. |
| Preamendent | Critikon Dura-Cuf® | Critikon Company, LLC |
| K991525 | Sterile Neonatal Blood Pressure Cuff | Deroyal Industries, Inc. |
Legally Marketed Devices to which Substantial Equivalence is claimed:
Device Description:
The devices comprise 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 fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose.
The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.
- NiBP: non-invasive blood pressure
Intended Use:
Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement.
Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.
Conclusion:
The intended use and general construction as the predicate devices remain the same. The NBP cuffs are identical in fit, form and function to marketed products named in the table above.
The cuffs are made of similar materials and colour coding is aligned to support clinical use. Product labelling has been improved by measures to identify the correct size by arm circumference and arm length. It has been shown that product performance is given within the range the device can be used by clinicians.
The technological characteristics and the results of the performance data demonstrated that the NBP cuffs issued no new risks during design verification and validation which could question device use.
In accordance with the Federal Food and Cosmetic Act and 21 CFR Part 807, based on the information provided in this premarket notification Drager Medical AG & Co. KG concludes that the NBP Cuffs are safe, effective and substantially equivalent to the predicate devices as described in this application.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Draeger Medical AG&G Co., KG c/o Ms. Joyce Kilroy Draeger Medical System, Inc. 3135 Quarry Road Telford, PA 18969
NOV 2 4 2009
Re: K092999
Trade/Device Name: NBP Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: II (two) Product Code: 74 DXO Dated: September 25, 2009 Received: September 28, 2009
Dear Ms. Kilroy:
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 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 - Ms. Joyce Kilroy
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
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 Statement
510(k) Number (if known)
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Device Name
NBP Cuff
K C92999
Indications for Use
Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors.
Neonatal cuffs are designed for single-patient use.
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
W. Mat
ision Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(k) Number