(7 days)
Device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomanometer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Blood Pressure Monitor Model HT-110:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a blood pressure cuff (Model HT-110). It does not contain a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for AI/ML devices. Instead, the submission relies on the device being "virtually the same" as predicate devices and meeting established industry standards for performance.
Therefore, many of the requested items (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission for a blood pressure cuff.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) (Implied: the device passed these tests and is safe and effective). | The Model HT-110 cuff is "virtually the same" as Critikon adult devices. |
| Biocompatibility same as predicate devices. | Biocompatibility is "same as predicate devices." |
| Repeated inflations and testing to ANSI/AAMI SP-9. | The device passed "Repeated inflations and testing to ANSI/AAMI SP-9." (This is the primary performance standard referenced, implying it met the criteria within that standard, though specific values are not given). |
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 specified. The submission mentions "Bench and laboratory testing" but does not detail the number of subjects or tests.
- Data Provenance: Not specified.
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/Not specified. This device is a manual blood pressure cuff, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- Not applicable. This is a blood pressure cuff, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (blood pressure cuff), not an algorithm. Its operation involves manual inflation and a "manual method for detecting Korotkoff sounds."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the implied ground truth would be accepted reference measurements for blood pressure as defined by the ANSI/AAMI SP-9 standard. The standard itself would dictate the procedures for establishing accuracy.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set.
Summary of the Study (as described in the 510(k) summary):
The submission describes bench and laboratory testing conducted to demonstrate the safety and effectiveness of the Nissei Blood Pressure Monitor Model HT-110. The core of the evidence relies on the device being "virtually the same as the Critikon adult devices" (predicate devices) and complying with the ANSI/AAMI SP-9 standard for blood pressure monitors. Biocompatibility was also asserted to be the same as the predicate devices.
The information provided is a concise summary aimed at demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearances. It does not elaborate on the specific details of performance studies in the way a clinical trial report for a novel AI algorithm might.
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510(k) Summary
JUL 2 0 2001
012194 p/2 K#
| Date: | |
|---|---|
| Contact | I. IshllNihon Seimitsu Sokki Co., Ltd.2508-13 Nakago KomochiKitagunma Gunma377-0293Japan |
| Telephone: | 81-279-20-2311 |
| Telefax: | 81-279-20-2411 |
| SubmissionCorrespondent | J. Harvey KnaussDelphi Consulting Group11874 South Evelyn CircleHouston, Texas 77071-3404 |
| Telephone | 713-723-4080 |
| E-fax | 208-694-6953 |
| harvey@delphiconsulting.com | |
| Device Name | Blood Pressure Monitor Model HT-110 |
| Common Name | Blood Pressure Cuff |
| Classification | The classification name, 21 CFR Part and Paragraph number, productcode and classification of the Nissei Blood Pressure Monitor Model HT-110 follow. The tier categorization is also included. |
| Classification Name | 21 CFR Section | Product Code | Class | Tier |
|---|---|---|---|---|
| Blood Pressure cuff | 870.1120 | DXQ | II | 2 |
| Stethoscope(Optional) | 870.1875 | I(exempt) |
| Predicate Devices | The Nissei Blood Pressure Monitor, Model HT-110 is substantiallyequivalent to following: |
|---|---|
| ------------------- | ---------------------------------------------------------------------------------------------- |
| Device | Manufacturer | 510(k) K# | |
|---|---|---|---|
| Critikon | Johnson & Johnson | K974080 | |
| SoftCheck Cuff | Statcorp, Inc. | K940214 |
| Device Description | The device comprises tubing attached to a soft inelastic sleeve with anintegrated inflatable bladder that is wrapped around the patient's limband secured by hook and loop closure. The device tubing is connectedto a non-invasive sphygmomanometer. |
|---|---|
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
510(k) Submission Page #
27
370-03-01-014
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KO12194 p2/2
- Device is intended to be used by medical professionals or in the home Indications for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. Technological The Model HT-110 cuff is virtually the same as the Critikon adult Characteristics devices. All of these devices are configured for use with a wide variety of manual and automated sphygmomanometers. Bench and laboratory testing was conducted to demonstrate Performance performance (safety and effectiveness) of the Model HT-110 cuff. Biocompatibility same as predicate devices. Repeated inflations and testing to ANSI/AAMI SP-9. In accordance with the Federal Food, Drug and Cosmetic Act and 21 Conclusions CFR Part 807, and based on the information provided in this premarket notification, Nihon Seimitsu Sokki Co., Ltd., concludes that the Model HT-110 Blood Pressure Cuff, is safe and effective and substantially equivalent to the predicate devices as described herein. Nihon Seimitsu Sokki Co., Ltd., will update and include in this summary Other any other information deemed reasonably necessary by the FDA.
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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2001
Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Mark Job TüV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
Re: K012194
KorzzyTrade Name: Blood Pressure Monitor (Sphygmomanometer), Model HT-110 Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II (two) Product Code: DXQ Dated: July 12, 2001. Received: July 13, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave leviewed your becally in the device is substantially equivalent (for the indications for use above and we nave determined the avedicate devices marketed in interstate commerce stated in the enerosary to regary masses of the Medical Device Amendments, or to devices that prior to may 20, 1970, are chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may) , merceive, is more of the Act include requirements for annual provisions of the rea. " rea" res. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 icharter Approval), it may of success of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections; the Food and Dation may result in regulatory action. In addition, FDA may publish
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Page 2 - Mr. Mark Job
further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarker notheaters stations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematic notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA miding of backansa of the super 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 and IT you desire specific acrite for your as to received the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (301) 594-4040. Addinonally, for questions of are processes onte the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please of Chicago entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsionnies and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ken Tellh
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K 012194
Device Name: Blood Pressure Monitor Model Ht-110
Indications for use:
Device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012194
Prescription Use _
OR
Over-The-Counter Use Yes
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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§ 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).