(114 days)
Not Found
No
The device description details standard automatic sphygmomanometer technology using pressure oscillation detection and basic circuitry, with no mention of AI or ML terms or capabilities.
No.
The device is a blood pressure monitor intended for measurement and diagnosis, not for treating a condition.
Yes
The device is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate, which are used to assess a patient's physiological state and identify potential medical conditions.
No
The device description explicitly mentions hardware components such as air pumps, electric valves, button controls, circuitry, LCD displays, an arm cuff, an AC adaptor, and a rechargeable battery.
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 DM-3000 system is a blood pressure monitor. It measures physiological parameters (blood pressure and pulse rate) directly from the patient's body using a cuff and pressure sensors. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate". This is a direct physiological measurement, not an in vitro test.
Therefore, the DM-3000 system falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachial artery
Indicated Patient Age Range
adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above
Intended User / Care Setting
physicians or under supervision of a physician.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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
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 :
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.
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)
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