The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated.

Device Description

The ERKA. Perfect-Aneroid Sphygmomanometer is an established manual noninvasive blood pressure measurement device that facilitates the auscultatory measuring method of Riva Rocci / Korotkoff. The ERKA. Perfect-Aneroid Sphyqmomanometer is designed to non-invasively measure the systolic and diastolic blood pressure of adult and paediatric, but not neonatal patients together with a common stethoscope. The ERKA. Perfect-Aneroid Sphygmomanometer contains the following components:

the manometer consisting of the main body, gauge, valve, bulb and spoon and
the cuff consisting of cover, bladder and tubing.
The ERKA. Perfect-Aneroid comes in two model types: As Model ERKA. Perfect-Aneroid 48, with a 48mm scale diameter scale and as ERKA. Perfect-Aneroid 56, with a 56mm scale diameter. Both types differ solely in the size of the scale. The larger scale allows an easier reading, e.g. for users with reduced eyesight. The smaller 48mm device realizes a weight advantage while ensuring equal precision and functionalitv.
The ERKA. Perfect-Aneroid gauge works with a traditional gear driven pointer movement that is triggered by pressure induction on a sealed membrane. The manometer features a brass chrome plated housing and a membrane protecting 2tube technology. The mechanics function in exactly the same way in both diameter sizes. The device comes with a polyurethane coated wipeable cuff. The duo-tubing is made of latex-free silicone and the inflatable bladder in the cuff is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510(k) clearance K071885 and K001333. The cuffs may be obtained in the following sizes:
Pediatric: Limb circumference 14 cm 21.5 cm
Small adult: Limb circumference 20.5 cm 28 cm
Adult: Limb circumference 27 cm 35 cm
Large Adult: Limb circumference 34 cm 43 cm
Thigh: Limb circumference 42 cm 54 cm 54 cm '

AI/ML Overview

Here's an analysis of the provided text to extract the requested information, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a manual, non-invasive blood pressure measurement device (sphygmomanometer). These types of devices operate based on well-established physical principles and human interaction, unlike AI/ML-driven devices. Therefore, many of the questions related to AI/ML studies, ground truth establishment for algorithms, training sets, and expert consensus/adjudication methods will not be applicable or explicitly stated in this type of submission. The focus here is on demonstrating substantial equivalence to a predicate device, primarily through technical specifications and adherence to recognized standards for accuracy.

Acceptance Criteria and Device Performance Study for ERKA. Perfect-Aneroid Sphygmomanometer

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Device/General Standards for Sphygmomanometers)	Reported Device Performance (ERKA. Perfect-Aneroid)
Measurement range: 0-300 mmHg	Measurement range: 0-300 mmHg
Measurement accuracy: +/- 3 mmHg	Measurement accuracy: +/- 3 mmHg
Scale graduation: 2 mmHg	Scale graduation: 2 mmHg
Scientific concept: Non-invasive, non-automated blood pressure measurement by means of auscultation of Korotkoff and Riva Rocci sounds	Scientific concept: Non-invasive, non-automated blood pressure measurement by means of auscultation of Korotkoff and Riva Rocci sounds
Intended Use: Non-invasive blood pressure measurement of adult and pediatric patients	Intended Use: Non-invasive blood pressure measurement of adult and pediatric, but not neonatal patients
Pressure measurement: Aneroid principle	Pressure measurement: Aneroid principle
Pressure induction: Manually by pump bulb	Pressure induction: Manually by pump bulb
Pointer movement: Gear driven	Pointer movement: Gear driven
Biocompatibility standards met for cuffs	Cuffs meet required biocompatibility standards

Explanation of the "Study" and Basis for Performance Claims:

The primary "study" or basis for demonstrating that the ERKA. Perfect-Aneroid meets its acceptance criteria is a substantial equivalence comparison to a legally marketed predicate device (RUDOLF RIESTER PRECISA N Blood Pressure Sphygmomanometer, K972379), rather than a prospective clinical trial in the modern sense of AI/ML device evaluations.

For traditional medical devices like manual sphygmomanometers, performance is often established by:

Demonstrating that the device adheres to recognized national or international standards for sphygmomanometers (e.g., ANSI/AAMI SP10, ISO 81060-1). While these aren't explicitly referenced as the "study" itself in this summary, the accuracy and range specifications (+/- 3 mmHg, 0-300 mmHg) are standard requirements from such norms.
Showing that the fundamental scientific concept, technical characteristics, and materials are the same or result in equivalent performance to a predicate device that has previously met these standards.

The submission highlights identical or equivalent technical specifications (measurement range, accuracy, scale graduation, principle of operation, etc.) to the predicate device. These performance metrics are inherent to the design and manufacturing of the device and are expected to be verified through quality control and testing according to relevant standards, though the specific testing methodology is not detailed as a separate "study" report in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided 510(k) summary. For a manual sphygmomanometer demonstrating substantial equivalence, performance is often verified through bench testing and, potentially, a small number of human subject validations conforming to standards like AAMI SP10. The summary does not provide details on such a "test set" in the context of subject recruitment or data collection.
Data Provenance: Not explicitly stated. Given it's a German manufacturer, initial developmental testing would likely occur in Germany. However, for 510(k) submission, adherence to recognized international standards is key.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable in the AI/ML sense. For a manual sphygmomanometer, "ground truth" for blood pressure measurements would typically be established by highly trained clinicians or reference devices (e.g., mercury sphygmomanometer, invasive arterial line) during validation studies. The 510(k) summary does not detail the number or qualifications of such experts, as it is focused on technical equivalence rather than a specific clinical validation study report for this submission.

4. Adjudication Method for the Test Set

Not Applicable in the AI/ML sense. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where multiple human readers interpret medical images or data and discrepancies are resolved. For a manual blood pressure device, performance is evaluated against established reference measurements, typically through statistical analysis of differences (e.g., Bland-Altman analysis if it were a clinical validation study). This summary does not describe such an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, not performed as described for AI/ML. MRMC studies are specific to evaluating how AI impacts human reader performance (e.g., radiologists interpreting images). This device is a standalone manual measurement tool and does not employ AI or involve human-in-the-loop performance augmentation for interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, in the sense that its performance is inherent to its design and manufacturing. While not an "algorithm" in the AI sense, the device’s ability to accurately measure blood pressure to +/- 3 mmHg is its standalone performance, independent of human interpretation beyond simply reading the gauge. The 510(k) summary relies on the device's technical specifications being identical or equivalent to the predicate, which itself would have demonstrated this standalone accuracy.

7. Type of Ground Truth Used

Reference Measurements/Standards. For manual blood pressure devices, the "ground truth" during device validation is typically established against highly accurate reference methods, such as a calibrated mercury sphygmomanometer or an invasive arterial line. The specified accuracy requirement of +/- 3 mmHg is derived from widely accepted international standards for sphygmomanometers. This summary doesn't detail the method of ground truth collection for its specific internal verification, but it would align with these established standards.

8. Sample Size for the Training Set

Not Applicable. This device is not an AI/ML system that requires a "training set" for model development.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set is used for this type of device.

Summary

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ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission

K103637

Section 5 = 510(k) summary

JUN - 8 2011

1/2

(as described in CFR 807.92 Content and format of a 510(k) summary chapter (a), (1) to (6))

(1)
Submitted by:	ERKA. Kallmeyer Medizintechnik GmbH & Co. KGIm Farchet 1583646 Bad TölzGermanyTel.: +49 (0)8041 / 8009-0Fax: +49 (0)8041 / 8009-39
Contact:	Jan Weiss, Quality Manager
Date prepared:	24 November 2010
(2)
Name of Device:	ERKA. Perfect-Aneroid sphygmomanometer
Common Name:	Blood Pressure Sphygmomanometer
Classification Name:	Blood Pressure Cuff; DXQ; 870.1120
(3)
Predicate Device:	RUDOLF RIESTER PRECISA N Blood PressureSphygmomanometer510(k) Document Control No.: K972379

(4)

Description of the device:

the manometer consisting of the main body, gauge, valve, bulb and spoon and - the cuff consisting of cover, bladder and tubing.

The ERKA. Perfect-Aneroid comes in two model types: As Model ERKA. Perfect-Aneroid 48, with a 48mm scale diameter scale and as ERKA. Perfect-Aneroid 56, with a 56mm scale diameter. Both types differ solely in the size of the scale. The larger scale allows an easier reading, e.g. for users with reduced eyesight. The smaller 48mm device realizes a weight advantage while ensuring equal precision and functionalitv.

The ERKA. Perfect-Aneroid gauge works with a traditional gear driven pointer movement that is triggered by pressure induction on a sealed membrane. The

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ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission

manometer features a brass chrome plated housing and a membrane protecting 2tube technology. The mechanics function in exactly the same way in both diameter sizes. The device comes with a polyurethane coated wipeable cuff. The duo-tubing is made of latex-free silicone and the inflatable bladder in the cuff is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510(k) clearance K071885 and K001333. The cuffs may be obtained in the following sizes:

Pediatric: Limb circumference 14 cm 21.5 cm
Small adult: Limb circumference 20.5 cm 28 cm
Adult: Limb circumference 27 cm 35 cm
Large Adult: Limb circumference 34 cm 43 cm
Thigh: Limb circumference 42 cm 54 cm 54 cm '

(5)

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Intended Use statement:

Restrictions:

The ERKA. Perfect-Aneroid sphygmomanometer is only to be used with ERKA. cuffs. Cuff size recommendations must be complied with in order to ensure blood pressure accuracy and safety,

(6)

Predicate Device Comparison Table

	ERKA. Perfect-Aneroid(48/56 mm scale diameter)	Riester precisa N(63 mm scale diameter)
General
Scientific concept	non-invasive, non-automated bloodpressure measurement by means ofauscultation of the Korotkoff andRiva Rocci sounds	non-invasive, non-automated bloodpressure measurement by meansof auscultation of the Korotkoff andRiva Rocci sounds
Intended Use	non-invasive blood pressuremeasurement of adult and paediatric,but not neonatal patients	non-invasive blood pressuremeasurement of adult and paediatricpatients
Pressuremeasurement	aneroid principle	aneroid principle
Pressure induction	manually by pump bulb	manually by pump bulb
Technicalcharacteristics
Design of Device	manometer including gauge and valve, cuff including inflatable bladder and tubing	manometer including gauge and valve, cuff including inflatable bladder and tubing
Pointer movement	gear driven	gear driven
Measurement range	0-300 mmHg	0-300 mmHg
Measurement accuracy	+/- 3 mmHg	+/- 3 mmHg
Dimensions	ERKA. dimensions as per datasheet. Dimensions of predicate device slightly different, however this does not have influence on performance
Scale diameter	48mm or 56mm diameter, (technological solution remains exactly the same)	63mm
Scale graduation	2mmHg	2mmHg
Tubing	membrane protecting 2-tube concept	membrane protecting 2-tube concept
Tube material	silicone, latex-free	unknown
Valve	Precision air release valve	Precision air release valve
Cuff incl. bladder	PU coated wipeable, latex-free material	Various cotton and nylon cuffs
Cuff size	various	various
Material grades of housing and body	Partly different material grades used. Difference does not affect performance.
Inflation method	manually by means of pump bulb	manually by means of pump bulb
Bulb material	latex-free, medical grade PVC	not known
Patient labeling
Device identification	individual, traceable device number	individual, traceable device number
Instructions for Use2	as per Guidance on Medical Device Patient Labeling, IFU included in package	as per Guidance on Medical Device Patient Labeling, IFU included in package
Packaging container labeling	label on outer container identifies model, article no., manufacturer, serial no. and content	label on outer container identifies model, article no., manufacturer, serial no. and content
Device labeling	gauge clearly identifies measuring range, unit, device no.; manufacturer, model, symbol for IFU; cuff clearly identifies size, range, latex-free information, artery marking, manufacturer, cuff positioning	gauge clearly identifies measuring range, unit, device no.; manufacturer, model, symbol for IFU; cuff clearly identifies size, range, artery marking, manufacturer, cuff positioning
Indications for Use	The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated.	Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-measurement)3

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ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission

. . . . .

3 The RIESTER statement is shorter, however signifies fundamentally the same meaning. As required by European and FDA regulations ERKA. determined the Indications for Use in greater detail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 The IFUs of the ERKA. devices and the predicate device may be found in Appendix B

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ERKA. Kallmeyer Medizintechnik GmbH & Co. KG c/o Mr. Alexander Schapovalov TUV SUD America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891

JUN - 8 2011

Re: K103637

Trade/Device Names: ERKA. Perfect-Aneroid Sphygmomanometer and Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXO Dated: May 18, 2011 Received: May 20, 2011

Dear Mr. Schapovalov:

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. Alexander Schapovalov

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 (OS) 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/Resourcesfor You/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

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K103637

Section 4 - Indications for use statement

510(k) Number:	Unknown
Device Name:	ERKA. Perfect-Aneroid sphygmomanometer
Indications for Use:	The ERKA. Perfect-Aneroid sphygmomanometer isintended for the non-invasive blood pressuremeasurement of adult and paediatric, but not neonatalpatients. The device is not designed, sold or intended foruse except as indicated.

Prescription Use Over-The-Counter Use yes Prescription 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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________ ר 103637

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).