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.

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.

AI/ML Overview

The provided 510(k) summary for the Dräger NBP Cuff (K092999) does not contain detailed information regarding specific acceptance criteria, a corresponding study, or performance metrics beyond a general statement of "product performance is given within the range the device can be used by clinicians."

This submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on design and intended use, rather than a detailed performance study with specific quantitative acceptance criteria.

Therefore, the requested information cannot be fully extracted from the provided text.

However, based on the context of a 510(k) submission for a non-invasive blood pressure cuff, we can infer general expectations and provide what little information is present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative performance metrics. However, for a blood pressure cuff, typical performance criteria would involve:Accuracy and precision of blood pressure measurement (often validated against direct arterial measurements).Comfort and fit for various patient demographics.Durability and material safety.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not mentioned. Given this is a medical device accessory (cuff) rather than an AI-driven diagnostic tool, "ground truth" in the AI sense would not typically apply here. Performance would be validated against established measurement standards and potentially clinical trials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, this is not an AI device. This question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is a physical medical device accessory (cuff). This question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated. For a medical device like a blood pressure cuff, performance data would likely involve comparing measurements obtained with the cuff against a gold standard method (e.g., direct arterial line measurement), or against predicate devices in controlled clinical settings, rather than "ground truth" derived from expert consensus on diagnostic images or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that would require a training set.

Summary of available information:

The 510(k) submission for the Dräger NBP Cuff (K092999) primarily relies on demonstrating substantial equivalence to existing predicate devices. It states that "product performance is given within the range the device can be used by clinicians" and that "design verification and validation" showed no new risks. However, it does not provide specific quantitative acceptance criteria or detailed results from a performance study (e.g., sample sizes, specific performance metrics, or study methodology) that would typically be associated with such criteria. The submission confirms general safety, effectiveness, and substantial equivalence based on its intended use, general construction, materials, and technological characteristics being similar to predicate devices.

Summary

{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, ModelsSC 8000, SC 7000 & SC 9000XL & SiemensInfinity Explorer(cuffs from supplier Statcorp)	Dräger Medical System, Inc(former Siemens MedicalSolutions USA, Inc.)
K022482	Sensa-Cuf	GE Medical Systems InformationTechnologies
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 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)

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ

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)

Over-The-Counter Use

W. Mat

ision Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 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).