(262 days)
The Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)
Transfer Technology reusable neurostimulator electrodes are laminated flexible materials widely used in this application.
Top layer Vinyl tape or non-woven fabrics with biocompatible adhesive
Second layer Grade "A" pure tin or electrically conductive carbon with Ag or Ag/AgCl
Third layer 1.25" flexible vinyl tape with biocompatible adhesive laminated around the outer perimeter of electrode
Patient layer Conductive hydrogel Amgel AG703
Lead Wire Constructed of a silicone-insulated stainless steel yarn wire with a standard 080" recessed female contact crimped and then insulated to one end By design, the insulated contact prevents the conductive connection to earth or hazardous voltages as required in IEC 60601-1 Subclause 56 3(c) Wire assembly is in compliance with FDA performance standard 21 CFR Part 898
The provided text describes a 510(k) submission for the "PRO-TECH Delivery System Electrodes." This is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through quantitative performance metrics. Therefore, many of the requested sections are not applicable in this context.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" and "device performance" in the context of specific numerical metrics (like sensitivity, specificity, accuracy) is not applied to this type of device (electrodes) in a 510(k) submission as it would be for, say, an AI diagnostic tool. Instead, safety and effectiveness are established through substantial equivalence to predicate devices. The "performance" here relates to the materials used and the comparison to established predicate devices.
| Acceptance Criterion (implicitly by substantial equivalence) | Reported Device Performance (based on comparison) |
|---|---|
| Intended Use Equivalence: Electrodes function as a disposable, conductive adhesive interface between patient's skin and electrical stimulator (TENS, EMS, MANS). | Met: Intended use is identical to predicate devices. |
| Technological Characteristics Equivalence: Similar component usage and physical properties. | Met: Critical components (Amgel AG703) are the same as used in predicate devices. |
| Material Biocompatibility: Materials are safe for skin contact. | Met: Top layer Vinyl tape or non-woven fabrics with biocompatible adhesive. Third layer 1.25" flexible vinyl tape with biocompatible adhesive. Patient layer Conductive hydrogel Amgel AG703. These are implicitly considered safe as per predicate. |
| Electrical Conductivity/Integrity: Effective electrical interface. | Met: Second layer Grade "A" pure tin or electrically conductive carbon with Ag or Ag/AgCl. Lead wire constructed of silicone-insulated stainless steel yarn. Performance assumed similar to predicate due to shared critical components. |
| Mechanical Integrity/Durability: Robust construction for intended use. | Met: Laminated flexible materials widely used in this application. Performance assumed similar to predicate. |
| Compliance with Standards: Adherence to relevant safety standards for electrical medical devices. | Met: Lead wire assembly in compliance with FDA performance standard 21 CFR Part 898 (IEC 60601-1 Subclause 56 3(c) for insulated contact). |
| Labeling Equivalence: Consistent with predicate labeling for safe and effective use. | Met: Labeling substantially equivalent to predicate devices. |
| Packaging Equivalence: Maintains device integrity and shelf life. | Met: Electrodes stored in a 2-mil poly re-sealable bag to comply with hydrogel manufacturer's shelf life. Labeling compliant to 21CFR Part 801. |
Study Details (Not Applicable for this type of 510(k) submission)
The provided document describes a 510(k) for neurostimulation electrodes. For such a device, the primary method of demonstrating safety and effectiveness is through a comparison to substantially equivalent predicate devices, rather than a clinical study with new performance data. Therefore, many of the requested study details are not relevant or present in this type of submission.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set data is provided. Non-clinical testing involved comparison of critical components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of performance data is described for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
- 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 diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for diagnostic or AI performance is not relevant here. The ground for "substantial equivalence" is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. There is no AI component or "training set."
- How the ground truth for the training set was established: Not applicable.
Explanation from the document:
- Non-clinical Testing: "The critical components used in Transfer Technology PRO-TECH Delivery System electrodes (Amgel AM703 K983741) are the same as used in the predicate devices. Therefore there is no reason to believe that the Transfer Technology PRO-TECH Delivery System electrodes will perform any different than the predicate device." This indicates that the "study" was primarily a component comparison and justification of equivalence based on shared materials and existing predicate data, rather than new performance testing.
- Clinical Testing: The document explicitly states "Not Applicable." This confirms that no clinical studies were performed to establish performance or safety for this 510(k) submission.
Conclusion:
The "study" demonstrating that the device meets acceptance criteria is based on the principle of substantial equivalence to already legally marketed and established predicate devices. The manufacturer argues that because their device uses the same critical components and has similar technological characteristics and intended use as these predicates, it is equally safe and effective. No new, independent performance study with defined acceptance criteria and data analysis (as would be expected for a novel diagnostic device or AI algorithm) was conducted or required for this 510(k) clearance.
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JAN 2 9 2009
Koss1279
/
510(k) Summary
| Submitter's Information | Joseph J ArbourTransfer Technology37822 Oxford DriveMurrieta, CA 92562Phone 951-677-0631Fax 951-677-0631 | |
|---|---|---|
| Date of Preparation | May 6, 2008 | |
| Proprietary Name | PRO-TECH Delivery System Electrodes | |
| Common Name | Neurostimulation Electrodes | |
| Classification Name | Electrodes, Cutaneous | |
| Predicate Device | K000870 (Katecho Inc )K970426 (Axelgaard Manufacturing)K875284 (Medtronic Inc ) | |
| Description of Device | Electrodes, Cutaneous | |
| Intended Use | The Transfer Technology PRO-TECH Delivery Systemelectrodes are intended for use as a disposable, conductiveadhesive interface between the patient's skin and the ElectricalStimulator Transfer Technology's reusable electrodes aredesigned and intended to be used with marketed ElectricalStimulators, i.e. TENS (Transcutaneous Electrical NerveStimulation), EMS (Electrical Muscular Stimulation), and MANS(Muscle and Neurological Stimulators) | |
| Technological Comparison | The Transfer Technology PRO-TECH Delivery Systemelectrodes exhibit technological characteristics that aresubstantially equivalent to those of the predicate device, asdetermined by both component usage and physical testing | |
| Labeling Comparison | The labeling of Transfer Technology PRO-TECH DeliverySystem electrodes substantially equivalent to those of thepredicate devices | |
| Device Description | Transfer Technology reusable neurostimulator electrodes arelaminated flexible materials widely used in this application | |
| Top layer Vinyl tape or non-woven fabrics with biocompatibleadhesive | ||
| Second layer Grade "A" pure tin or electrically conductivecarbon with Ag or Ag/AgCl | ||
| Third layer 1.25" flexible vinyl tape with biocompatible adhesivelaminated around the outer perimeter of electrode | ||
| Patient layer Conductive hydrogel Amgel AG703 | ||
| Device Description(continued) | Lead Wire Constructed of a silicone-insulated stainless steelyarn wire with a standard 080" recessed female contactcrimped and then insulated to one end By design, the insulatedcontact prevents the conductive connection to earth orhazardous voltages as required in IEC 60601-1 Subclause56 3(c) Wire assembly is in compliance with FDA performancestandard 21 CFR Part 898 | |
| Non-clinical Testing | The critical components used in Transfer TechnologyPRO-TECH Delivery System electrodes(Amgel AM703 K983741) are the same as used in thepredicate devices Therefore there is no reason to believe thatthe Transfer Technology PRO-TECH Delivery System electrodeswill perform any different than the predicate device | |
| Clinical Testing | Not Applicable | |
| Packaging | Electrodes are stored in a 2-mil poly re-sealable bag to complywith the shelf life specifications of the hydrogel manufacturerLabeling is compliant to 21CFR Part 801 | |
| Conclusion | The Transfer Technology PRO-TECH Delivery Systemelectrodes are substantially equivalent to those of the submittedpredicate devices and any difference between the devices do notpose new questions of safety and effectiveness |
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized strokes forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transfer Technology % Mr Joseph J Arbour 37822 Oxford Drive Murrieta, California 92562
JAN 2 3 2009
Re K081279
Trade/Device Name PRO-TECH Delivery System Electrodes Regulation Number 21 CFR 882 1320 Regulation Name Cutaneous electrode Regulatory Class II Product Code GXY Dated November 17, 2008 Received November 17, 2008
Dear Mr Arbour
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 pror 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 Joseph J Arbour
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Mark N Milham
Mark N Melkerson 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
| 510(k) Number (if known) | K081279 |
|---|---|
| Device Name | PRO-TECH Delivery System Electrodes |
| Indications For Use | The Transfer Technology PRO-TECH DeliverySystem electrodes are intended for use as adisposable, conductive adhesive interfacebetween the patient's skin and the ElectricalStimulator Transfer Technology's reusableelectrodes are designed and intended to be usedwith marketed, Electrical Stimulators, i.e. TENS(Transcutaneous Electrical Nerve Stimulation),EMS (Electrical Muscular Stimulation), and MANS(Muscle and Neurological Stimulators) |
Prescription Use (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)
David Keane by MKM 1/23/2009
Division Sign-Off
Jivision of General, Restorative. and Neurological Devices
Page 1 of __
~~(k) Number K081279
§ 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).