PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

K023616 · Ivy Biomedical Systems, Inc. · DRT · Nov 4, 2002 · Cardiovascular

Device Facts

• Record ID: K023616
• Device Name: PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
• Applicant: Ivy Biomedical Systems, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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.

Device Story

Ivy Biomedical Model 3000 is a patient monitor for ICU, CCU, and OR environments. Device inputs include ECG signals via patient leads. It processes these signals to calculate heart rate and detect R-waves. Outputs include visual heart rate monitoring, audible alarms for heart rate limit violations, and an electrical output pulse synchronized to the R-wave for external equipment requiring precision synchronization. Operated by trained medical professionals to assist in clinical decision-making regarding patient cardiac status. Benefits include continuous cardiac monitoring and reliable synchronization for ancillary medical devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiac monitor (21 CFR 870.2300). Features ECG signal acquisition, heart rate calculation, alarm thresholding, and R-wave synchronized pulse output. Designed for clinical environment use.

Indications for Use

Indicated for monitoring ECG and heart rate in ICU, CCU, and operating room settings. Intended for use by trained medical professionals only. Not for home use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

K023616

| 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