(87 days)
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
The provided document is a 510(k) summary for a medical device called the SVL-9130 Defibrillation Electrode. It details the device's administrative information, predicate devices, intended use, and a brief statement about its performance.
However, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance. Specifically, it states:
"The SVL-9130 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and SurVivaLink's internal specifications. In all instances, the SVL-9130 electrodes functioned as intended."
This is a general statement of compliance, but it does not provide:
- Specific acceptance criteria: The document refers to "AAMI DF-39 specifications" and "SurVivaLink's internal specifications" but does not list or describe them.
- Reported device performance: It doesn't present any quantitative results (e.g., impedance measurements, defibrillation efficacy rates, adhesion strength, etc.) that would demonstrate how the device "functioned as intended" against those specifications.
- Details about the study: There is no information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or any form of comparative effectiveness study (MRMC) or standalone performance study.
Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to existing standards rather than presenting detailed study results.
Here's what I can extract from the document regarding studies and performance, but it's very limited:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from AAMI DF-39 and SurVivaLink internal specifications) | Reported Device Performance |
|---|---|
| Not specified in the document (e.g., impedance, adhesion, current delivery efficacy) | "met all the specifications" |
| Not specified in the document | "functioned as intended" |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document indicates adherence to technical specifications, not human interpretation-based ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This typically applies to studies where human interpretation of data (like medical images) is involved, which is not the case described here.
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:
- No, an MRMC study was not done or reported. This device is an electrode, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. The "standalone" performance here would refer to the physical and electrical performance of the electrode itself, which they state "met all the specifications" but provide no specific data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the electrodes appears to be defined by the technical specifications of AAMI DF-39 and SurVivaLink's internal specifications, which likely include physical, electrical, and biocompatibility standards. No biological or clinical ground truth (like pathology or outcomes) is mentioned in relation to specific performance data.
8. The sample size for the training set:
- Not applicable/Not specified. This device is not an AI algorithm that undergoes "training."
9. How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
1997 - JUN 223 1997 - 1997 - 1997 - 1997
ATTACHMENT H: 510(K) SUMMARY
(
{1}------------------------------------------------
510(k) Summary
H-1. ADMINSTRATIVE INFORMATION
H-1.1 Name and address
| Submitted by: | SurVivaLink Corporation5430 Feltl RoadMinneapolis, MN 55343 |
|---|---|
| --------------- | --------------------------------------------------------------------- |
| Contact Person: | Sew-Wah Tay, Ph.D. |
|---|---|
| Telephone No.: | 612-939-4181 ext. 142 |
| Facsimile No .: | 612-939-4191 |
Date Prepared: March 26, 1997
H-1.2 Device Name
| Common or Usual Name: | Disposable Polymer (Hydrogel) External Monitoring andDefibrillation Electrode |
|---|---|
| Device Name: | SVL-9130 |
| Trade Name: | SVL-9130 |
H-1.3 Classification Name
Disposable Single Use Accessory (Electrode) to:
a) Semi-automatic low energy DC defibrillator 21CFR§870.5300; Class II
b) Cardiac Monitor (Cardiotachometer and Rate Alarm) 21CFR§870.2300; Class II
Note: FDA has determined that Automatic External Defibrillators are currently classified as class III devices
H-1.4 Applicant
Applicant's Name:
SurVivaLink, Corporation 5430 Feltl Road Minneapolis, MN 55343
PREDICATE DEVICE H-2.
-
- SurVivaLink Model 9010 (9010) electrodes manufactured for SurVivaLink Corporation by Katecho Inc.models (K940445)
-
- Katecho K-Defib/Pace electrodes (K914955)
H-3. INDICATION FOR USE
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of
{2}------------------------------------------------
disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
H-4 DEVICE DESCRIPTION
The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
SUBSTANTIAL EQUIVALENCE H-5.
The Company's SVL-9130 electrodes covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the SVL-9130 electrode is substantially equivalent to SVL-9010 electrodes (K940455) and Katecho's D-Defib/Pace electrodes (K 914955).
PERFORMANCE DATA H-6.
The SVL-9130 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and SurVivaLink's internal specifications. In all instances, the SVL-9130 electrodes functioned as intended.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 1997
Sew-Wah Tay, Ph.D. SurVivaLink Corporation 5420 Feltl Road · · · ······· Minneapolis, Minnesota 55343
Re: K971149 SurVivaLink 9130 Defibrillation Electrode Regulatory Class: III (three) Product Code: 74 MKJ Dated: March 27, 1997 Received: March 28, 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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 Fart 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 - Sew-Wah Tay, Ph.D.
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
8. INDICATION FOR USE
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Prescription use ✓
K12m
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_kg7114
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.