The Zipprep Electrode is a single patient use, disposable pre-gelled electrode that is applied directly to the patient's forehead to record electro-physiological signals.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zipprep Electrode, a cutaneous electrode used for recording physiological signals. This submission seeks to demonstrate substantial equivalence to a predicate device, focusing on minor design changes rather than clinical performance.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or therapeutic efficacy, is not applicable to this 510(k) submission.

Here's why and what information is relevant:

The device is an electrode, a Class II device. The 510(k) filing primarily addresses design changes (shape, material of snap stud, tape, and shelf life) from a previously cleared device. The focus is on demonstrating that these changes do not raise new questions of safety or effectiveness, not on proving clinical accuracy or diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria:
- Biocompatibility in accordance with ISO10993.
- Electrical testing as per ANSI-AAMI EC12:2000.
- Maintain same indications for use as predicate.
- Maintain same intended use as predicate.
- Maintain same fundamental scientific technology as predicate.
- Maintain same basic design (with minor modifications noted).
- Maintain biocompatibility.
- Achieve an 18-month shelf life.
Reported Device Performance (as stated in the submission materials):
- Biocompatibility testing performed in accordance with ISO10993 was referenced to support the device.
- Electrical testing performed as per ANSI-AAMI EC12:2000 was referenced to support the device.
- The device has the "Same indications for use," "Same intended use," "Same fundamental scientific technology," "Incorporates the same basic design" (with noted minor differences), and is "Biocompatible."
- The device has an "18 month shelf life."
- The submission asserts that these modifications "do not raise new questions of safety or effectiveness."
- The FDA's decision of "substantial equivalence" indicates the device met their criteria for market clearance.

2. Sample size used for the test set and the data provenance:

Not applicable for clinical performance. The document refers to "Biocompatibility testing" and "electrical testing." These are likely bench tests on a sample of the electrodes, not a clinical test set with human subjects for performance evaluation in the context of diagnostic accuracy. The specific sample sizes and provenance for these engineering tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth in a clinical diagnostic sense was established for a "test set" in this submission. The tests referenced (biocompatibility, electrical) are standard engineering and safety tests, not clinical evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was conducted or referred to.

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:

Not applicable. This device is an electrode, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Engineering Standards and Benchmarking: The "ground truth" here is defined by compliance with established international and national standards for medical devices (ISO10993 for biocompatibility and ANSI-AAMI EC12:2000 for electrical performance). The comparison to the predicate device also serves as a "ground truth" of sorts, as the predicate's performance is already accepted.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K070069
Page 1 of 2

FEB 5 2007

510 K SUMMARY

Date:	January 04, 2007Aspect Medical Systems, Inc.,One Upland Road, Norwood MA 02062
Contact Person:	Vikram VermaPhone: (617) 559-7134Fax: (617) 559-7948
Proprietary Name:	Zipprep Electrode
Common Name:	Electrode, Cutaneous Electrode
Classification:	Class II device. Refer to 21 CFR 882.1320
Product Code:	GXY
Predicate Devices:	Aspect Medical Systems Zipprep Electrode510(k), # K940802, received FDA clearance on June 22, 1994.Aspect Medical Systems Zipprep EEG Sensor510(k)#K961821, received FDA clearance on October 04, 1996.
Device Description:	The Zipprep Electrode is a single patient use, disposable pre-gelledelectrode that is applied directly to the patient's forehead to recordelectro-physiological signals.
Indications for Use:	The Zipprep Electrode is applied directly to the patient's skin toenable recording of physiological signals.

Similarities and Differences:

....

Similarities:

. Same indications for use.
. Same intended use.
Same fundamental scientific technology. .
Incorporates the same basic design. .
Biocompatible. .

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K070069
Page 2 of 2

Differences:

The Zipprep Electrode has the following minor differences from the predicate device:

. Shape changed from "tear drop" to "rectangular".
. Stainless steel snap stud
. Polypropylene tape
18 month shelf life .

Biocompatibility testing, in accordance with ISO10993, and electrical testing as per ANSI-AAMI EC12:2000 have been referenced to support the device.

In summary, the Zipprep Electrode is substantially equivalent to the predicate device. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as the predicate device. The indications for use remain the same as the Zipprep Electrode and Sensor. The fundamental scientific technology remains the same as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aspect Medical Systems, Inc. % Mr. Vikram Verma Manager, Regulatory Affairs and Quality Assurance 1 Upland Road Norwood, Massachusetts 02062

5 2007 FEB

Re: K070069

Trade/Device Name: Zipprep Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: January 5, 2007 Received: January 8, 2007

Dear Mr. Verma:

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.

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. Vikram Verma

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), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known)

C70069

Device Name

Zipprep Electrode

Indications For Use

The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.

: :

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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 General, Restorative, and Neurological Devices
	C-2
510(k) Number	1070069
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Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).