(6 days)
The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
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The provided text is an FDA 510(k) clearance letter for the Ivy Biomedical Model 3000 Patient Monitor. It does not contain the detailed information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) summary typically includes a brief description of the device, its intended use, a comparison to a predicate device, and a summary of performance data (often in the form of a statement of substantial equivalence). However, it generally does not provide the granular technical details or study methodologies you're asking for.
The letter explicitly states: "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..." This heavily implies that the clearance was based on demonstrating equivalence to an existing device, rather than a novel study with specific acceptance criteria that would then be detailed.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size used for the test set and data provenance: Not present.
- Number of experts used to establish ground truth and qualifications: Not present.
- Adjudication method: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size: Not present.
- Standalone (algorithm only) performance: Not explicitly discussed, as this is a patient monitor, not an AI algorithm in the context you're suggesting.
- Type of ground truth used: Not present.
- Sample size for the training set: Not present (and likely not applicable in the context of this type of device and clearance).
- How the ground truth for the training set was established: Not present.
The only information that can be extracted related to the device and its use is from the "Indications for Use Statement" (Attachment 3):
- Device Name: Ivy Biomedical Model 3000
- Indications for Use: "The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring."
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMEN ! HE MANSE
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2002
Ivy Biomedical Systems, Inc. c/o Mr. Dick Listro Director of Regulatory Affairs 11 Business Park Drive Branford, CT 06405
Re: K023616
Trade Name: Ivy Biomedical Model 3000 Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: DRT Dated: October 25, 2002 Received: October 29, 2002
Dear Mr. Listro:
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.
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Page 2 - Mr. Dick Listro
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 (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. This letter will allow you to begin marketing your device as described in your Section 5.10(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) 594-4646. Additionally, for questions on the promotion and advertising of vour 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,
Q.6.7. Telle
Bram D. Zuckerman, M.D.
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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IVY BIOMEDICAL SYSTEMS, INC
| ATTACHMENT 3: |
|---|
| --------------- |
| Indications for Use Statement | |
|---|---|
| -- | ------------------------------- |
| 510(k) Number | (K023616) |
|---|---|
| Device Name | Ivy Biomedical Model 3000 |
| Indications for Use | The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use
Division of Cardiovascular & Respiratory Devices
510(K) Number K023614
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).