(57 days)
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.
These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with conductive centers, composed of materials commonly used in this application:
- First Layer: Stainless Steel snap, that works as a connection point for the diagnostic equipment.
- Second Layer: Polypropylene label substrate, used for reinforcement and a printable surface for branding.
- Third Layer: Various materials i.e., medical grade polyester fabric, polyethylene foam and paper, coated with bio-compatible adhesive.
Fourth Layer: Ag/AgCl. coated, 20% carbon filled plastic sensor.
Gel Foam Layer: Polyurethane foam. Only used for conductive wet gel.
Conductive Gel: Bio-compatible conductive solid hydrogel or wet gel
Fifth Layer: Silicone coated release liner to cover the adhesive and conductive media.
The electrodes are disposable and designed for single-patient use. They have a low profile construction that uses soft pliable and conformable materials for patient comfort. Because of the adhesive nature no extra securing materials are required to anchor the device to the patient's skin. The electrodes have one universal contact point which is a stainless steel snap. The equipment manufacturers provide the receptacle to this in the form of cither a snap lead wire or a pinch clip.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shanghai Intco Electrode Manufacturing Co.'s Disposable EKG monitoring electrodes:
Limited Information Provided:
It's important to note that the provided text is a 510(k) summary, which often focuses on substantial equivalence to predicate devices rather than a detailed, standalone clinical study report. Therefore, many of the requested elements (especially those related to human reader studies, training sets, and detailed ground truth establishment) are generally not present in this type of document. The study described is primarily a laboratory-based performance and biocompatibility study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Shanghai Intco electrodes are implicitly based on demonstrating performance equivalent to predicate devices and meeting specific AAMI standards and biocompatibility requirements. The document states that the electrodes are "as safe and effective as Lead-Lok Inc. electrodes" and underwent specific tests.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-1) | Test results attached (implies successful) |
| Sensitization (ISO 10993-1) | Test results attached (implies successful) | |
| Primary Skin Irritation (ISO 10993-1) | Test results attached (implies successful) | |
| Electrical Performance | Bias Current Tolerance (AAMI standards) | Test results attached (implies successful) |
| DC Offset Voltage (AAMI standards) | Test results attached (implies successful) | |
| AC Impedance (AAMI standards) | Test results attached (implies successful) | |
| Combined Offset and Internal Noise (AAMI standards) | Test results attached (implies successful) | |
| Recovery Slope Time (AAMI standards) | Test results attached (implies successful) | |
| AC Impedance after Defib (AAMI standards) | Test results attached (implies successful) |
Note: The document explicitly states "test results attached," indicating that the performance met the thresholds associated with these industry standards, thereby satisfying the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The tests are laboratory-based electrical performance and biocompatibility tests, not clinical studies with patient data. For biocompatibility, tests are typically conducted on material samples using in vitro or animal models, not human patients as a "test set."
- Data Provenance:
- Biocompatibility: The conductive gels (wet gel and solid hydrogel) and adhesive-backed materials underwent testing. The solid hydrogel formula was acquired from Vermont Medical. The origin of the raw materials and testing laboratories is not specified beyond "medical grade."
- Electrical Performance: Tests were run according to AAMI standards. These are laboratory bench tests.
- Retrospective or Prospective: These are laboratory and material-based tests, not human subject studies in the traditional sense. Therefore, the terms retrospective or prospective don't directly apply. The testing was performed on the device materials and finished product before submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this 510(k) summary. The "ground truth" for these types of devices is established by adherence to recognized electrical and biocompatibility standards (AAMI and ISO 10993-1). There is no mention of expert human readers or ground truth established by medical professionals in this context for evaluating the device's fundamental performance.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretative "test set" requiring adjudication in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. The device is a monitoring electrode, and its effectiveness is assessed through its electrical performance and biocompatibility, not by human interpretation of images or signals that would typically involve an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive electrode, not an algorithm or AI system. Its performance is inherent to its physical and electrical properties.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's safety and effectiveness is established by:
- Adherence to recognized industry standards:
- Biocompatibility: ISO 10993-1 requirements for skin contact (Cytotoxicity, Sensitization, Primary Skin Irritation).
- Electrical Performance: AAMI standards for EKG monitoring electrodes (Bias Current Tolerance, DC Offset Voltage, AC Impedance, Combined Offset and Internal Noise, Recovery Slope Time, and AC Impedance after Defib).
- Substantial equivalence to predicate devices: The predicate devices (Lead-Lok Inc. K832877, K911518/D) had previously been determined safe and effective.
In essence, the "ground truth" is that if the device meets these standards and is equivalent to the predicate, then it is considered safe and effective.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or AI/ML algorithm involved.
{0}------------------------------------------------
SEP 1 5 2004
Image /page/0/Picture/1 description: The image shows the text "K041954 p.1/2". The text appears to be handwritten. The text is black and the background is white.
Shanghai Intco Electrode Manufacturing Co. 510(k) Summary
The following information is submitted in accordance with the requirements of 21 CFR 807.92
| Submitter's name: | Shanghai Intco Electrode Manufacturing Co., LTD |
|---|---|
| No. 555 Hubin Road, Zhelin Town, FengXian District | |
| Shanghai, PR China 201417 | |
| Phone: 011 86 21 5745 1159 Ext. 849 | |
| Fax: 011 86 21 5745 1877 | |
| dsun@basicmedical.com |
| Contact person: | Don Sun, General Manager |
|---|---|
| Date Prepared: | July 8, 2004 |
| Device Name: | Disposable EKG monitoring electrodes |
| Common/Usual Name: | Monitoring Electrodes |
| Classification Name: | Electrodes, cutaneous |
| Predicate devices: | Lead-Lok Inc. K832877. K911518/D |
Device Description: These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with conductive centers, composed of materials commonly used in this application:
- First Layer: Stainless Steel snap, that works as a connection point for the diagnostic equipment.
- Second Layer: Polypropylene label substrate, used for reinforcement and a printable surface for branding.
- Third Layer: Various materials i.e., medical grade polyester fabric, polyethylene foam and paper, coated with bio-compatible adhesive.
Fourth Layer: Ag/AgCl. coated, 20% carbon filled plastic sensor.
Gel Foam Layer: Polyurethane foam. Only used for conductive wet gel.
Conductive Gel: Bio-compatible conductive solid hydrogel or wet gel
Fifth Layer: Silicone coated release liner to cover the adhesive and conductive media.
Page 8
{1}------------------------------------------------
The electrodes are disposable and designed for single-patient use. They have a low profile construction that uses soft pliable and conformable materials for patient comfort. Because of the adhesive nature no extra securing materials are required to anchor the device to the patient's skin. The electrodes have one universal contact point which is a stainless steel snap. The equipment manufacturers provide the receptacle to this in the form of cither a snap lead wire or a pinch clip.
Technological Characteristics: Our clectrodes are technologically equivalent to the predicate devices. They are physically and technically similar to those currently being marketed for ECG/EKG Cardiac monitoring, EEG brain wave monitoring, Bio-beedback and nerve sensing.
Safety and Effectiveness: Our electrodes are as safe and effective as Lead-Lok Inc. electrodes which were previously found to be substantially equivalent via 510(k) Premarket Notification K832877 and K911518/D.
The only two points of contact to the patients skin are the conductive gel and the adhesive-backed base material. Both conductive gels (wet gel and solid hydrogel), underwent the required skin sensitivity testing criteria as specified in the Triportite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization, and Primary Skin Irritation (test results attached). As you will see, the solid hydrogel test results mention the name Vermont Medical, Lead-Lok/Shanghai Intco acquired this formula from Vernont Medical through a technology exchange. The adhesive backed materials are purchased from outside suppliers that use medical grade adhesive and also adhere to the same test criteria (test results attached)
The effectiveness of the electrodes was determined by running tests according to AAMI standards i.e., Bias Current Tolerance, DC Offset Voltage, AC Impedance, Combined Offset and Internal Noise, Recovery Slope Time and AC Impedance after Defind (test results attached).
For the above reasons, Shanghai Intco Electrode Manufacturing Co. considers its disposable electrodes to be as safe and effective as the predicate devices.
Page 9
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a symbol of medicine and healing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2004
Shanghai Intco Electrode Manufacturing Co. Ltd. c/o Mr. Chris Healy Lead-Lok Inc. 500 Airport Way Sandpoint, ID 83864
Re: K041954
Trade Name: Disposable ECG Monitoring Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrodes Regulatory Class: Class II (two) Product Code: DRX Dated: September 01, 2004 Received: September 07, 2004
Dear Mr. Healy:
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
{3}------------------------------------------------
Page 2 - Mr. Chris Healy
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. 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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Brimma for
Brad D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) NUMBER: KO41954
DEVICE NAME: Disposable ECG/EKG (Electrocardiogram) sensing electrodes
INDICATIONS FOR USE:
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR:
Over-the Counter-Use (Optional Format 1-2-96)
Blatissima
ion Sign-Off) Division of Cardiovascular Device Page 5
510(k) Number K041954
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.