(28 days)
Not Found
No
The description focuses on a disposable electrode for recording physiological signals and does not mention any AI/ML components or functionalities.
No.
The device is used for recording physiological signals (diagnosis), not for treating a disease or condition.
No
The device records physiological signals, but it does not analyze them or provide a diagnosis. Its function is limited to signal acquisition, which is a component of diagnostic processes but not a diagnostic act in itself.
No
The device description explicitly states it is a "disposable pre-gelled electrode," which is a physical hardware component applied to the patient's skin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enable recording of physiological signals" by being "applied directly to the patient's skin". This describes a device that interacts with the patient's body to collect data, not a device that tests samples taken from the body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description reinforces this by stating it's a "pre-gelled electrode that is applied directly to the patient's forehead to record electro-physiological signals." This is a surface electrode for physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or performing tests on biological specimens outside the body, which are hallmarks of IVD devices.
Therefore, the Zipprep Electrode is a medical device for physiological signal recording, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.
Product codes
GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's forehead, patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing, in accordance with ISO10993, and electrical testing as per ANSI-AAMI EC12:2000 have been referenced to support the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K070069
Page 1 of 2
FEB 5 2007
510 K SUMMARY
| Date: | January 04, 2007
Aspect Medical Systems, Inc.,
One Upland Road, Norwood MA 02062 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vikram Verma
Phone: (617) 559-7134
Fax: (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 Electrode
510(k), # K940802, received FDA clearance on June 22, 1994.
Aspect Medical Systems Zipprep EEG Sensor
510(k)#K961821, received FDA clearance on October 04, 1996. |
| Device Description: | 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. |
| Indications for Use: | The Zipprep Electrode is applied directly to the patient's skin to
enable 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. .
1
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.
2
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.
3
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
4
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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