(146 days)
The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.
Biofeedback Device
The provided document is limited in detail regarding specific acceptance criteria and a detailed study report. However, based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated as safe in clinical study. |
| Efficacy (Stress Reduction/Adjunctive BP Treatment) | Demonstrated a clinically significant reduction in high blood pressure over 8 weeks. |
| Proper OTC Use (without physician direction) | Demonstrated to be properly usable without the direction of a physician in clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical testing in the OTC setting" and a "clinical study," but does not provide the number of participants.
- Data Provenance: Not explicitly stated, but the submission is from InterCure Ltd. in Lod, Israel. Without further information, it's difficult to confirm geographical origin. The study appears to be prospective as it "demonstrated a safe, clinically significant, reduction in high blood pressure with use of the RESPeRATE over a period of 8 weeks."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
The RESPeRATE is a biofeedback device, not an image analysis or diagnostic AI tool that would typically involve human "readers." Therefore, an MRMC comparative effectiveness study involving human readers is not applicable to this device. The study focused on the device's direct effect on blood pressure and user's ability to use it without physician guidance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The RESPeRATE is a biofeedback device that requires user interaction. While it likely contains internal algorithms for guiding breathing and monitoring, its performance is inherently human-in-the-loop. The clinical study evaluated the device's performance when used by individuals, demonstrating its effect as an adjunctive treatment and its usability in an OTC setting. Therefore, a purely standalone algorithm test (without human interaction) is not applicable in the context of this device's intended use.
7. The Type of Ground Truth Used
The ground truth appears to be based on clinical outcomes data, specifically:
- Measurement of blood pressure reduction over an 8-week period.
- Observation and assessment of the user's ability to properly use the device in an OTC setting without physician guidance.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. It refers to "clinical testing" and a "clinical study" which seem to encompass the evaluation of the device's performance.
9. How the Ground Truth for the Training Set was Established
As no separate training set is mentioned, this information is not provided. The clinical study mentioned would have served to establish the efficacy and safety for the device itself.
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020399 1/2
ATTACHMENT 9
510(k) Summary For The InterCure Ltd. RESPeRATE
Submitter's Name, Address, Telephone Number, and Contact Person
ﺴﺮ
InterCure Ltd. 9 Hamelacha st. Kislev building Northern Industrial area, Lod, 71520 Israel
| Contact: | Dr. Benjamin GavishChief Scientist, InterCure Ltd |
|---|---|
| Phone: | 972-8-9212126 |
| Facsimile: | 972-8-9204001 |
| Email: | bgavish@intercure.com |
Date Prepared: January 2002
Name of the Device
RESPeRATE
Common or Usual Name
Biofeedback Device
Predicate Device
Respi-Low Model RL-108 (K000495) manufactured by InterCure Ltd .;
Intended Use
The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.
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Summary of the Basis for the Finding of Substantial Equivalence
The RESPeRATE is substantially equivalent to InterCure's previously cleared Respi-Low biofeedback device (K000495) for use in stress reduction and adjunctive treatment to reduce blood pressure. The device shares the same general intended use in relaxation and/or stress reduction and the same indications for use except for OTC use. Moreover, the principles of operation are identical to the predicate device and there are only minor differences in technological characteristics. Clinical testing in the OTC setting has shown that the RESPeRATE device can be properly used without the direction of a physician. This difference in the specific indications for use of the RESPeRATE (for OTC use) compared to the predicate (for prescription use), however, does not raise new questions of safety or efficacy and does not alter its therapeutic effect. Moreover, the clinical study demonstrated a safe, clinically significant, reduction in high blood pressure with use of the RESPeRATE over a period of 8 weeks without the guidance of a physician. Therefore, the devices are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized representation of a human figure with three profiles overlapping each other. The profiles are arranged in a way that creates a sense of depth and continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
InterCure LTD. c/o Jonathan S. Kahan Hogan and Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109
Re: K020399 Trade Name: RESPeRATE Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: May 9, 2002 Received: May 9, 2002
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
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Page 2 -- Mr. Jonathan S. Kahan
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K 020 399
Device Name: InterCure Ltd. RESPeRATE
Indications for Use:
The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use X
(Per 21 C.F.R. 801.109) (Optional Format 1-2-96)
Hyatt Murda
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZO3999 510(k) Number_
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.