(152 days)
Not Found
No
The device description explicitly states that the device is passive and does not contain active electronics, software, or firmware. There is no mention of AI or ML in the document.
No
The device is an accessory to high-frequency surgical equipment, acting as a neutral electrode for electrosurgery, which is a surgical procedure and not a therapeutic one itself.
No.
The device is described as an accessory to surgical equipment for cutting and coagulation of human tissue, not for diagnosis. It is a neutral electrode used with electrosurgical generators.
No
The device description explicitly states that the device "do[es] not contain active electronics, software or firmware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use with electrosurgical generators for cutting and coagulation of human tissue". This describes a surgical accessory used on the patient's body during a procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description clearly states it's an "accessory to surgery devices" and is applied to "intact (uninjured) skin". IVDs are typically used to analyze biological samples like blood, urine, tissue, etc.
- Performance Studies: The performance studies listed are related to electrical and physical properties relevant to its function as a surgical electrode (thermal performance, contact impedance, adhesion), not analytical performance metrics associated with IVDs (sensitivity, specificity, etc.).
In summary, the Skintact Neutral Electrodes for Neonates are a surgical accessory used during electrosurgery, not a device for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).
Product codes
GEI
Device Description
Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Skintact® Neutral Electrodes for Neonates consist of a backing material, conductive layer and conductive adhesive gel. The Neutral Electrodes for Neonates are applied on a release liner. The only change in construction materials is a slight modification of the conductive hydrogel. This modification was carried out to adapt the gel to the skin of neonates. Skintact® Neutral Electrodes for Neonates are accessories to surgery devices.
Skintact® Neutral Electrodes for Neonates are passive devices and do not contain active electronics, software or firmware Skintact® Neutral Electrodes for Neonates are packaged in water-vapour-proofed, heat-sealed, non-transparent, aluminized pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).
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)
Performance testing was conducted according standard EN60601-2-2:2009 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009), relevant clauses.
EN60601-2-2:2009, 201.15.101.5 - NE thermal performance- including comparative thermal performance testing against predicate product.
EN60601-2-2:2009, 201.15.101.6 - NE contact impedance
EN60601-2-2:2009, 201.15.101.7 - NE adhesion
Release test with electrodes aged at +23°C for 43 days and Shelf life test with accelerated aged electrodes at increased temperature of +75°C for 43 days.
According EN60601-2-2:2009, 201.15.101.8. Results are within limits.
Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks. Skintact® Neutral Electrodes for Neonates are NON-STERILE so there was no sterility testing required.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(K) SUMMARY
JUL 2 9 2014
This 510(k) summary has been prepared in accordance with the requirements of 21CFR 807.92:
Submitted on behalf of:
.
| Company Name:
Address: | Leonhard Lang GmbH
Archenweg 56
6020 Innsbruck
Austria |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | +43 512 334257
+43 512 392210 |
| Contact Person: | Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| Date prepared: | July 25, 2014 |
| Device Identification: | |
| TRADE NAME: | Skintact® Neutral Electrodes for Neonates
(and also to be offered for sale under various private label
tradenames) |
| COMMON NAME: | Neutral Electrodes |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and
accessories |
| PRO CODE: | GEI |
| Regulation No.: | 21CFR 878.4400 |
| Classification: | Class II |
| SUBSTANTIALLY EQUIVALENT TO: | |
| K063161 | Leonhard Lang Skintact® Cool Contact Electrosurgical
Grounding Plates, Leonhard Lang GmbH with NH04 Gel,
decision date: 11/21/2006 |
| K030362 | Leonhard Lang Skintact® Cool Contact Electrosurgical
Grounding Plates, Leonhard Lang GmbH, decision date:
04/14/2003 |
| K994428 | E7512 Premie REM PolyHesive II Patient Return Electrode |
INDICATIONS FOR USE:
Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).
Valleylab Inc., decision date: 03/07/2000
Traditional 510(k): Skintact® Neutral Electrodes for Neonates
1
510(k) Summary-Continued
DESCRIPTION of the DEVICE:
Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Skintact® Neutral Electrodes for Neonates consist of a backing material, conductive layer and conductive adhesive gel. The Neutral Electrodes for Neonates are applied on a release liner. The only change in construction materials is a slight modification of the conductive hydrogel. This modification was carried out to adapt the gel to the skin of neonates. Skintact® Neutral Electrodes for Neonates are accessories to surgery devices.
Skintact® Neutral Electrodes for Neonates are passive devices and do not contain active electronics, software or firmware Skintact® Neutral Electrodes for Neonates are packaged in water-vapour-proofed, heat-sealed, non-transparent, aluminized pouches.
SUMMARY of TESTING:
Performance and Standards:
Performance testing was conducted according standard EN60601-2-2:2009 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009), relevant clauses.
EN60601-2-2:2009, 201.15.101.5 - NE thermal performance- including comparative thermal performance testing against predicate product.
EN60601-2-2:2009, 201.15.101.6 - NE contact impedance
EN60601-2-2:2009, 201.15.101.7 - NE adhesion
Release test with electrodes aged at +23°C for 43 days and Shelf life test with accelerated aged electrodes at increased temperature of +75°C for 43 days.
According EN60601-2-2:2009, 201.15.101.8. Results are within limits.
Biocompatibility and Sterility:
Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.Skintact® Neutral Electrodes for Neonates are NON-STERILE so there was no sterility testing required.
Substantial Equivalence Summary [21CFR 807.92(a) (6)]
Skintact® Neutral Electrodes for Neonates have the same indications for use as Skintact® Cool Contact Electrosurgical Grounding Plates approved in existing 510(k)s K030362 and K063161, expanded with the addition of target group "neonates" like approved in existing 510(k) K994428.
| Comparison of Indications for Use | ||||
|---|---|---|---|---|
| K030362, K063161 | This submission | K994428 | ||
| similar | Skintact® Cool Contact | |||
| Electrosurgical | ||||
| Grounding Plates | Skintact® Neutral | |||
| Electrodes for | ||||
| Neonates | The E7512 Neonatal | |||
| REM PolyHesive™ II | ||||
| Neonatal Patient | ||||
| Return Electrode | similar | |||
| SAME | are designed for use | |||
| with electrosurgical | ||||
| generators for cutting | ||||
| and coagulation of | ||||
| human tissue. | are designed for use | |||
| with electrosurgical | ||||
| generators for cutting | ||||
| and coagulation of | ||||
| human tissue | is single use, non- | |||
| sterile dispersive with | ||||
| a preattached cord. | ||||
| The electrode adheres | ||||
| to the patient over its | ||||
| entire surface. Its | ||||
| purpose is to complete | ||||
| the electrosurgical | ||||
| circuit between the | ||||
| generator, the active | ||||
| electrode, and the | similar |
Traditional 510(k): Skintact® Neutral Electrodes for Neonates
2
510(k) Summary-Continued
| | | patient.
Indications for use are
general monopolar
electrosurgery on | | |
|----|----|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------|
| -- | -- | of newborn or
prematurely born
patients of between
approximately 1 | newborn or
prematurely born
patients of between
approximately 1 | SAME |
| -- | -- | and 11 lbs. | and 6 lbs. | similar |
The patient weight range of Skintact® Neutral Electrodes for Neonates is indicated according standard EN60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
Skintact® Neutral Electrodes for Neonates are substantially equivalent to predicate devices
| Comparison | K030362
K063161 | Skintact® Neutral
Electrodes for
Neonates | K994428 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------|
| Technical
Characteristics /
Features | single patient use | | |
| | disposable | | |
| | self-adhesive | | |
| | non-sterile | | |
| | for use on
adults and children | for use on
neonates (newborn or prematurely born) | |
| Packaging | sealed foil pouch | | unknown |
| Testing | Based on biocompatibility testing and electrical and adhesive
performance testing of the electrodes the devices are safe and effective
when used according instructions for use. | | |
| Construction | > Backing material
Conductive layer
Conductive adhesive hydrogel
Cover material | | |
CONCLUSION:
The introduction of the Skintact® Neutral Electrodes for Neonates (and also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and the Skintact® Neutral Electrodes for Neonates are substantially equivalent to the predicate device. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular and features a stylized caduceus symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
Leonhard Lang GmbH Ms. Elaine Duncan, M.S.M.E, RAC President, Paladian Medical Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K140500
Trade/Device Name: SkinTact® Neutral Electrodes for Neonates Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI Dated: June 26, 2014 Received: June 30, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Elaine Duncan, M.S.M.E, RAC
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K140500
Skintact® Neutral Electrodes for Neonates Device Name:
Indications for Use:
Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).
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)