(91 days)
PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.
PG47xW SERIES are disposable adhesive electrodes with solid conductive gel. They consist of a conductive pad made of three primary layers: a non-woven fabric top, a carbon filled film and a solid hydrogel adhesive layer. Between the conductive film and the insulating top a 10 cm long cable is attached, terminated with 2 mm touch proof socket for the connection with electro-stimulating devices. Multiple shapes and sizes are available to accommodate placement on various location on the body. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient's skin. The electrodes are non-sterile and for single patient use only.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for cutaneous electrodes (FIAB PG47xW SERIES). Its purpose is to demonstrate substantial equivalence to a predicate device (Valuetrode, K970426), not to present performance study data against
pre-defined acceptance criteria.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria: The document explicitly states: "Although there are no guidance performance standards, as reported in Section 18, the electrodes are produced and tested according to all requirements laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that there are no specific, quantitative acceptance criteria defined and presented in this summary for the device's performance.
- No Performance Study: The document claims equivalence based on "technological characteristics equivalent to those of the predicate devices" and that "The performance is expected to be the same as predicate device. See section 12 of the submission." Section 12 is referenced, but its content is not
provided in this summary. This suggests that a direct performance study to meet specific acceptance criteria was either not conducted or not detailed in this publicly available summary. Instead, it relies on the presumed safety and effectiveness of the legally marketed predicate device.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth establishment, expert involvement, or multi-reader studies. The document does not provide such details.
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K091163
510(K) Summary
Section 05
510(K) notification
Cutaneous Electrodes
JUL 22 2009
1/2
Submitter Information
FIAB SpA Via P. Costoli, 4 50039 Vicchio Florence - Italy
Phone: +39 055 84979216 Fax: +39 055 8497987 Contact person: Silvia Calabrò, Official Correspondent Email: silvia@fiab.it
Device name and classification
Trade name:
PG471W, PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB disposable electrodes with cable for electro-stimulation.
Common name: cutaneous electrode.
Classification name: cutaneous electrode (21 CFR 882.1320, Product code GXY)
Predicate device
Lawfully marked device to which is claimed equivalence:
| Trade Name | Manufacturer/Distributor | 510(K) Number |
|---|---|---|
| Valuetrode | AXELGAARD MFG. CO. TD. | K970426 |
Device description
PG47xW SERIES are disposable adhesive electrodes with solid conductive gel. They consist of a conductive pad made of three primary layers: a non-woven fabric top, a carbon filled film and a solid hydrogel adhesive layer. Between the conductive film and the insulating top a 10 cm long cable is attached, terminated with 2 mm touch proof socket for the connection with electro-stimulating devices. Multiple shapes and sizes are available to accommodate placement on various location on the body. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient's skin. The electrodes are non-sterile and for single patient use only.
FIAB spa - Via P. Costoli, 4 - 50039 VICCHIO - FLORENCE - ITALY 2 +39 0558497999 - Z +39 0558497979 - www.fiob.it
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510(K) Summary
Section 05
510(K) notification
Cutaneous Electrodes
Intended use
PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.
Comparison to predicate
PG47xW SERIES electrodes have technological characteristics equivalent to those of the predicate devices (ValueTrode electrodes previously cleared under K970426), employing the same solid gel (the only patient contacting component) and having equivalent technological characteristics including comparable design, materials and equivalcnt packaging and labeling.
Although there are no guidance performance standards, as reported in Section 18, the electrodes are produced and tested according to all requirements laid down by the regulations in force so as to guarantee safety and effectiveness.
According to the risk-benefit analysis, the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks.
The devices have the same intended use as the predicate devices. The performance is expected to be the same as predicate device. See section 12 of the submission.
04/17/2009
FIAB spa - Via P. Costoli, 4 - 50039 VICCHIO - FLORENCE - ITALY # +39 0558497999 -- 출 +39 0558497979 -- www.flab.it
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is printed in black ink.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FIAB SpA c/o Alberto Calabro Via Costoli, 4, Viccio Firenze. Italy 50039
JUL 2 2 2009
Re: K091163
Trade/Device Name: FIAB disposable electrodes models PG471W, PG471/50W, PG474W, PG477W. PG479/32W, PG479/50W, PG479/75W
Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: May 26, 2009 Received: June 9, 2009
Dear Mr. Calabro:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Alberto Calabro
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Dr. Callaway for
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Section 04
510(K) notification
Cutaneous Electrodes
Indications for Use
510(K) Number (if known): -
KO91463
Device Name:
FIAB disposable coutaneos electrodes, models: PG471W PG471/50W PG474W PG477W PG479/32W PG479/50W PG479/75W
Indications For Use:
PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND /OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
04/17/2009
Kog 1163 510(k) Number
1/1
FIAB spa - Via P. Costoli, 4 - 50039 VICCHIO - FLORENCE - ITALY 色 +39 0558497999 -- 喜 +39 0558497979 -- www.fiab.it
§ 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).