V2

K970481 · Survivalink Corp. · LDD · Jul 1, 1997 · Cardiovascular

Device Facts

• Record ID: K970481
• Device Name: V2
• Applicant: Survivalink Corp.
• Product Code: LDD · Cardiovascular
• Decision Date: Jul 1, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V2 semi-automatic external defibrillator is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient’s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The V2 is intended to be used on patients who weighs more than 90 lbs.

Device Story

FirstSave (Model 9100/9110) is a semi-automatic external defibrillator for emergency cardiac arrest treatment. Operated by trained personnel in clinical or field settings. Device inputs include patient ECG signals via electrodes; internal algorithm analyzes rhythm to determine shock necessity. If shockable rhythm detected, device prompts user to deliver defibrillation shock. Output consists of visual/audible prompts and electrical energy delivery. Benefits include rapid intervention for cardiac arrest. Device requires tracking per 21 CFR 821.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory review of device design and intended use.

Technological Characteristics

Semi-automatic external defibrillator; includes ECG sensing and electrical defibrillation circuitry. Designed for patients >90 lbs. Subject to device tracking requirements under 21 CFR 821.

Indications for Use

Indicated for emergency treatment of cardiac arrest in patients weighing >90 lbs. Must be used by trained personnel who have confirmed the patient is unconscious, pulseless, and not breathing.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

New-Wah Tay, Ph.D.
Manager of Regulatory Affairs and QA
SurVivaLink Corporation
5420 Feltl Road
Minneapolis, Minnesota 55343

JUL 1 1997

Re: K970481
FirstSave™ Automated External Defibrillator
Regulatory Class: III (three)
Product Code: 74 MKJ
Dated: June 17, 1997
Received: June 19, 1997

Dear Dr. Tay:

We have reviewed your Section 510(k) 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish 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 have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Sew-Wah Tay, Ph.D.

On August 16, 1993, the Final Rule for Device Tracking was published in the *Federal Register*, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993, *Federal Register* beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 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 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Please be advised that, in the future, FDA may require postmarket surveillance of this device under the authorities granted under section 522 of the Federal Food, Drug and Cosmetic Act. This issue is currently under consideration by FDA and you will be notified of our decision in writing.

Sincerely yours,

Thomas J. Caliahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page ___ of ___

510(k) Number (if known): K970481

Device Name: FIRST SAVE AUTOMATED EXTERNAL DEFINITION AND MODEL 9100/9110
(formerly V2)

# 8. INDICATION FOR USE

The V2 semi-automatic external defibrillator is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient’s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The V2 is intended to be used on patients who weighs more than 90 lbs.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)