The HEINE Gamma aneroid sphygmomanometers are non-invasive blood-pressure measurement devices to measure systolic and diastolic blood pressure in adults and pediatric patients. The HEINE Gamma sphygmomanometers consist of a large insufflation bulb, a gauge with a large diameter scale, a valve, and a single tube cuff with Velcro fastener.

The HEINE Gamma sphygmomanometers come in five models; G5, G7, GP, GST, and XXL LF. The models comprise either a push-button valve or a spin valve. The HEINE Gamma GST comprises an integrated stethoscope for self measurement. The HEINE Gamma XXL LF is a wall-, desk-, or rail-mounted devices and is available with a wheeled stand. HEINE Gamma G5, G7, GP, and XXL LF will be available in five cuff sizes; child small, child, adult small, adult, and thigh. The HEINE Gamma GST comes with an adult cuff.

The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care.

AI/ML Overview

The provided text describes the HEINE Gamma aneroid sphygmomanometers and their substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested.

The document states:

Bench Testing was conducted to demonstrate Safety and Effectiveness by conformance to the ANSI/AAMI SP9-1994 standard for non-automated Sphygmomanometers.

This indicates that the device's performance was evaluated against a recognized standard for non-automated sphygmomanometers. However, the specific acceptance criteria within that standard (e.g., maximum allowable error) and the reported device performance against those criteria are not detailed in the provided text.

Therefore, I cannot populate the table or answer most of the specific questions as the information is not present in the given document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

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

Cannot provide. The document states conformance to the ANSI/AAMI SP9-1994 standard, but it does not list the specific numerical acceptance criteria from that standard nor the actual measured performance of the HEINE Gamma devices against those criteria.

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

Cannot provide. The document mentions "Bench Testing" but does not detail the sample size or data provenance for any test set.

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 applicable for this type of device/study as described. For a blood pressure monitor, "ground truth" would typically come from a reference measurement (e.g., mercury sphygmomanometer) and not an expert consensus on interpreting images or clinical cases. The document does not describe such a process.

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

Not applicable/Cannot provide. Adjudication methods are typically used in studies involving expert review of ambiguous cases, which is not described for this device's testing.

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-assisted diagnostic device, but a manual blood pressure monitor. MRMC studies are not relevant here.

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

Not applicable. This is a manual, non-automated device, so there is no algorithm in the traditional sense or standalone performance to evaluate. The device itself is the "standalone" entity in terms of measurement.

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

Inferred: For blood pressure monitors, "ground truth" for accuracy studies typically involves comparison against a reference standard measurement, often a mercury sphygmomanometer or another highly accurate calibrated device. However, the document does not explicitly state the method of ground truth establishment.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not applicable. As above, no training set.

Summary

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K/0/892

510(k) Summary of Safety and Effectiveness

AUG 27 2010

In accordance with the requirements of the Safe Medical Device Act, HEINE Optotechnik GmbH & Co. KG herewith submits a Summary of Safety and Effectiveness.

Submitter Information:	HEINE Optotechnik GmbH & Co. KGKientalstr. 782211 HerrschingGermanyRegistration Number:1000379039Owner/Operator Number: 9003020
Official Correspondent:	Mrs. Claudia SchwiegerHead of Quality ManagementHEINE Optotechnik GmbH & Co. KGPhone: +49 8152 383 40
US Agent (Contact):	Benoit st. JeanHEINE USA, Itd.10 Innovation WayDover, NH 03820 USAPhone: +1 603 7427217E-mail: Bstjean@heine-na.com
Date Prepared:	July 02, 2010
Device(s) Identification:Device Trade Name:Common Name:	HEINE Gamma G7®; G5®; GP®; GST®; XXL LF®Non-Automated Sphygmomanometers
Classification of the device:Device Classification Name:Product Code:Device Classification No.:Panel:Regulatory Status:	Blood Pressure CuffDXQPart 870.1120CardiovascularClass II

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Predicate devices:

1.
Device Trade Name:	Riester Precisa N
Applicant:	RUDOLF RIESTER GMBH & CO. KG
510(k) No.:	K972379
2.
Device Trade Name:	Riester Risan
Applicant:	RUDOLF RIESTER GMBH & CO. KG
510(k) No.:	K002954
3.
Device Trade Name:	Riester Big Ben
Applicant:	RUDOLF RIESTER GMBH & CO. KG
510(k) No.:	K972301
4.
Device Trade Name:	Riester Sanaphon
Applicant:	RUDOLF RIESTER GMBH & CO. KG
510(k) No.:	K972378

The HEINE GAMMA aneroid sphygmomanometers are considered substantial equivalent to the Riester Precisa N (K972379), Riester Risan (K002954), Riester Big Ben (K972301), and Riester Sanaphon (K972378).

There is no significant difference in intended use or technology.

Device Description:

The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care.

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Intended Use:

The HEINE Gamma Sphygmomanometers are used for non-automated blood pressure measurement by professional and lay users. The devices are non-sterile and are intended as multi-patient reusable devices. The HEINE Gamma Sphygmomanometers are available in infant through adult sizes.

Summary of Non-Clinical Performance Testing:

Bench Testing was conducted to demonstrate Safety and Effectiveness by conformance to the ANSI/AAMI SP9-1994 standard for non-automated Sphygmomanometers, as referenced in the FDA Guidance Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1.

Conclusion:

HEINE Optotechnik believes that the HEINE Gamma aneroid sphygmomanometers are substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Heine Optotechnik,GmbH & Co., Kg c/o Mr. Thomas Weber PROSYSTEM AG Beim Strohhause 27 Hamburg, GERMANY 20097

AUG 27 2010

Re: K101892

Trade/Device Name: Heine GAMMA® Sphygmomanometers Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: July 5, 2010 Received: July 7, 2010

Dear Mr. Weber:

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.

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Page 2 - Mr. Thomas Weber

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W. Mad.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101892

HEINE GAMMA® Sphygmomanometers

Indications for Use

510(k) number (if known):

Device Name:

Indications For Use:

HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.W.B.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

Page 1 of __

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).