(132 days)
Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.
All Skintact® Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pediatric Multifunction Electrodes with DH03 Gel are composed of the same materials as the predicate device K073322 by Leonhard Lang except the modified DH03 Gel (made by Leonhard Lang).
The provided text describes a 510(k) submission for the "Skintact® Pediatric Multifunction Electrodes with DH03 Gel". The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of regulatory document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it states that the device "met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003". This implies that the acceptance criteria are defined by these international standards for defibrillation electrodes. The "reported device performance" is the statement that the device met these specifications.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI DF80:2003 (Defibrillation Electrodes) | Met specifications |
| IEC/EN 60601-2-4:2003 (Medical Electrical Equipment - Defibrillators) | Met specifications |
| ISO 10993 (Biocompatibility for intact skin) | Conducted and passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance testing or the provenance of the data (country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary but would be part of the full test reports.
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)
This is not applicable as the performance testing involved meeting engineering and biocompatibility standards, not clinical diagnosis or interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation was against technical standards and not subjective interpretation requiring adjudication.
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, and no MRMC study was conducted or is relevant to its substantial equivalence claim.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the electrodes themselves were tested against the specified standards (biocompatibility, electrical performance). This is an "algorithm only" equivalent for a physical device, where the "algorithm" is the device's design and materials performing its intended function. The testing did not involve human-in-the-loop performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is defined by the technical specifications and testing methodologies outlined in the referenced standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, and ISO 10993). These standards define acceptable performance parameters for biocompatibility and electrical characteristics of defibrillation electrodes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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KOf1371
SEP 2 4 2008
Archenweg 56 6020 Innsbruck
Leonhard Lang GmbH
510(k) Summary
SUBMITTER
Submitted on behalf of:
Company Name: Address:
Austria Telephone: ++ 43 / 512 / 33 4 25 7 Fax: ++ 43 / 512 / 39 22 10 Registration Number: 8020045 Owner/Operator Number: 8020045
by:
Elaine Duncan, MS.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: 715-549-6035 Fax: 715-549-5380
Contact Person: Date prepared: Trade Name:
Skintact® Pediatric Multifunction Electrodes with DH03 Gel (and as also to be offered for sale under various private label tradename) Common Name: Defibrillation Electrodes Classification Name: Dc-defibrillator, low-energy, (including paddles) Regulation: Defibrillators, Automatic, External, 21 CFR & 870.5310 Regulatory Class This device is Class III Device Panel and Product Code: 74 Cardiovascular, MKJ Reason for 510(k) Submission: new device
Elaine Duncan
May 12, 2008
Substantial Equivalence: Skintact® Pediatric Multifunction Electrodes with DH03 Gel are substantially equivalent to the stated predicate devices:
K992977 Hewlett Packard Multifunction Pediatric Defibrillation Electrodes
Leonhard Lang Skintact® Multifunction Electrodes with DH02 Gel available with different K072233 connectors compatible with different devices
Description of device: All Skintact® Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pediatric Multifunction Electrodes with DH03 Gel are composed of the same materials as the predicate device K073322 by Leonhard Lang except the modified DH03 Gel (made by Leonhard Lang).
Indications for use: Skintact® Pediatric Multifunction Elcctrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medironic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.
Basis for Equivalence - performance testing: Biocompatibility testing was conducted and passed ISO 10993 for intact skin. The performance data of Skintact® Pediatric Multifunction Electrodes with DH03 Gel and the predicate device (K072233) met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. The introduction of the Skintact® Pediatric Multifunction Electrodes (and as also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and the Skintact® Pediatric Multifunction Electrodes with DH03 Gel are substantially cquivalent to the predicate devices K992977 and K072233.
Traditional 510(k): Skintact® Pediatric Multifunction Electrodes with DH03 Gel
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the department's name. The department's name is arranged in a circular fashion around the caduceus. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 4
Leonhard Lang, GmbH c/o Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
Re: K081371
Trade/Device Name: Skintact® Pediatric Multifunction Electrodes with DH03 Gel Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ Dated: September 18, 2008 Received: September 22, 2008
Dear Ms. Duncan:
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.
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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. 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K0fi371
Indications for Use
510(k) Number (if known):
Device Name: Skintact® Pediatric Multifunction Electrodes with DH03 Gel
Indications For Use:
Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators: Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qmal
inn of Cardiovascular Devices
KORISTI 510(k) Number
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.