The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician.

Device Description

The Model DM-3000 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement of systolic and diastolic blood pressures and pulse rate in adult patients under the supervision of a physician. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes air pumps for automatic cuff inflation, electric valves, button controls, circuitry to detect and process minute pressure oscillations, a bar LCD to display mercury-column-like pressure flow and a segment LCD to display blood pressure and pulse rate as a digital value and operation indications such as inflation, measurement error and battery error. Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done, or manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery.

AI/ML Overview

Here's an analysis of the provided text regarding the Nissei Model DM-3000 Digital Blood Pressure Monitor with respect to acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) Premarket Notification Summary for a blood pressure monitor. These summaries often focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a full, independent clinical study with detailed acceptance criteria for a novel device. As such, some of the requested information (especially regarding performance thresholds, detailed study design, and expert involvement for "AI" or "algorithm" focused criteria) is not explicitly present because the device is a medical measurement instrument, not an AI diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

For the Nissei Model DM-3000 Digital Blood Pressure Monitor, the primary performance criterion is accuracy, which is assessed against the ANSI/AAMI Standard SP10-1992. The document states that the new device has the same measurement accuracy for both blood pressure and pulse rate as its predicate device. This implies that the predicate device's performance already met the ANSI/AAMI standard, and the new device maintains that performance.

Acceptance Criterion	Reported Device Performance
Blood Pressure Accuracy (per ANSI/AAMI SP10-1992)	"Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard.
Pulse Rate Accuracy (per ANSI/AAMI SP10-1992)	"Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard.
Electromagnetic Compatibility	Complies with IEC 60601-2, 2001 (with referenced amendments) and IEC 60601-1-2, 2001.

Note: Specific numerical accuracy thresholds (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, but would be defined by the ANSI/AAMI SP10-1992 standard.

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

The document mentions "clinical evaluation" but does not specify the sample size for any test set. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that this is a 510(k) for an update to an existing device, it's likely a relatively small clinical evaluation focused on confirming the equivalence of the updated features.

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

The document does not specify the number of experts or their qualifications for establishing ground truth during the clinical evaluation. For blood pressure monitors, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a auscultatory method with a mercury sphygmomanometer as the reference standard, following established protocols.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. For blood pressure monitor accuracy studies, multiple reference readings are often taken and averaged, but a formal adjudication process (like 2+1 or 3+1 for discordant readings) is not a typical requirement for establishing ground truth for simple physiological measurements like blood pressure in the same way it would be for image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance, and it's not applicable to a non-invasive blood pressure monitor.

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

Yes, a standalone performance evaluation of the device's automatic measurement capabilities was done. The description indicates:

"Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done..."
The clinical performance and accuracy testing was conducted against the ANSI/AAMI SP10-1992 standard, which is designed to evaluate the standalone performance of automated sphygmomanometers.

7. The Type of Ground Truth Used

For blood pressure monitors, the ground truth is typically established by expert reference measurements, specifically auscultatory readings obtained by trained clinicians using a calibrated reference device (often a mercury sphygmomanometer) in parallel with the device under test. This is the standard method specified in the ANSI/AAMI SP10 standard.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is a conventional blood pressure monitor, not an AI/ML-based algorithm that requires a "training set" in the machine learning sense. The device uses established oscillometric principles for measurement, validated through engineering design and a clinical evaluation.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. For traditional medical devices like blood pressure monitors, the "ground truth" concept applies to the validation or test set (as discussed in point 7), not a separate training set.

Summary

{0}------------------------------------------------

K061086

AUG 1 0 2006

SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address & Phone Number:

Nihon Seimitsu Sokki., Co., Ltd. (Nissei) 2508-13, Nakago,Komochi-Mura Kitagunma-Gun, Gunma-Ken 377-0293,Japan +81-0279-20-2311

Submission Correspondent:

Lyle Howard Corporation 106 East 5th Avenue Mount Dora, FL 32757 USA Attention: Lynette Howard 908-788-4580

Classification Name: Common / Usual Name: Proprietary Name:

Noninvasive Blood Pressure Monitor Blood Pressure Monitor Model DM-3000 Digital Blood Pressure Monitor

Establishment Registration Number: 9610827 Classification: Class II, Reg. # 870.1130, DXN, Cardiovascular Devices Panel

Performance Standard: Section 898 and 1010 of the Federal Food, Drug and Cosmetic Act

Substantial Equivalence:

The legally marketed device to which substantial will demonstrated is the Nissei Model DM-3000 Digital Blood Pressure Monitor. This device was cleared for marking under 510(k) No.K993890, SE decision December 3, 1999.

The subject device is essentially an updating of the predicate device. As can be seen in Appendix P, many of the features and performance specifications are identical. Note particularly that both systems contain a built-in air pump for automatic cuff inflation, have the same measurement accuracy for both blood pressure and pulse rate.

{1}------------------------------------------------

The principal differences are that the bar LCD to demonstrate mercury-column-like pressure flow is added to the new DM-3000 besides the segmental LCD to display pressure in a digital value as the predicate device and that optional function was added to switch the instrument to a pressure gauge with which inflation and deflation of the cuff is done automatically but the determination of blood pressure is made by a physician using a stethoscope. The setting of preset pressure and, for manual measurement, the setting of deflation rate, which the predicate device did not have, is also added to the subject device.

Because the difference between the subject device and the predicate device represent functional improvements that have been evaluated though both bench testing and clinical evaluation, it is clear that these changes raise no new questions with respect to either safety or effectiveness.

Testing conducted or standards applied to assure safety and effectiveness includes but is not limited to:

Clinical Performance and Accuracy: ANSI/AAMI Standard SP10-1992, Electronic or Automated Sphygmomanometers.

Electromagnetic Compatibility: IEC 60601-2, 2001 with test procedures according to IEC 61000-4-2, 2001; IEC 61000-4-3, 2001, IEC 61004-4, 2001 with Amendment 1, 2000 and Amendment 2, 2001; IEC 61004-6, 2001; IEC61004-4-8, 2001; IEC 61000-4-11, 2001.

Electromagnetic Interference: IEC 60601-1-2, 2001.

Description of the new device:

{2}------------------------------------------------

K06:036

manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2006

LDR Spine USA % Mr. James W. Burrows Director of Clinical Marketing 4030 West Braker Lane, Suite 360 Austin, Texas 78759

Re: K061017 Trade Name: Easyspine® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: July 19, 2006 Received: July 20, 2006

Dear Mr. Burrows:

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.

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.

{4}------------------------------------------------

Page 2 - Ms. Elizabeth A. Rosenfeld

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfummma for

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

Enclosure

{5}------------------------------------------------

Appendix C Revision 6 July 2006

510(K) Number: K061086

Model DM-3000 Digital Blood Pressure Monitor Device Name :

Indications For Use :

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ AND / OR (21 CFR 807 Subpart C)

(Per 21 CFR 801.109 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumlama

evices

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).