(134 days)
Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
This document is a 510(k) summary for the Iskra Medical Green IRF Prestige and Accessories, a device intended for non-invasive treatment of facial wrinkles and rhytids. The 510(k) submission primarily relies on substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and device performance metrics. Therefore, many of the requested details regarding acceptance criteria and study particulars are not explicitly provided in this document.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in terms of efficacy (e.g., reduction in wrinkle depth, patient satisfaction scores) from a dedicated study. The submission relies on demonstrating substantial equivalence to predicate devices based on indications for use, design, and functional features.
| Acceptance Criteria (Not explicitly stated/measured in this document) | Reported Device Performance (Not explicitly stated/measured in this document) |
|---|---|
| e.g., % reduction in wrinkle severity, safety profile, etc. | e.g., % of patients achieving a specific aesthetic outcome, adverse event rates |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set. The 510(k) summary focuses on demonstrating substantial equivalence.
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)
Not applicable. As no clinical study is described, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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 electrosurgical unit and accessories, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to this medical device, which is an electrosurgical unit. It does not employ an algorithm that would have standalone performance in the context of AI or diagnostic imaging.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established or used in this device's submission as it relies on substantial equivalence to predicate devices without presenting new clinical performance data for efficacy.
8. The sample size for the training set
Not applicable. No training set is mentioned as part of a study for this device.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for it is mentioned.
Summary of the document's approach:
The Iskra Medical Green IRF Prestige and Accessories device gained clearance based on the "V. Intended Use" and "VI. Rationale for Substantial Equivalence" sections.
- Intended Use: "The Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids."
- Rationale for Substantial Equivalence: The document states that the device "shares the same indications for use, similar design and functional features with predicate devices, and thus it has been found to be substantially equivalent to the predicate devices." The predicate devices listed are:
The FDA's letter (APR 17 2009) confirms this determination, stating: "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..."
Therefore, the "proof" the device meets acceptance criteria, in this context, is the demonstration to the FDA that it is substantially equivalent to already legally marketed devices, rather than a clinical study establishing new performance metrics against predefined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the text "K 083590" in a handwritten style, with the word "Iskra Medical" appearing below the numbers. A logo is placed between the numbers and the company name. The text and logo are in black and white, and the image appears to be a close-up of a document or label.
APPENDIX 2
APR 1 7 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Information
| Applicant: | Iskra Medical d.o.o.Stegne 23, 1000 Ljubljana, Slovenia |
|---|---|
| Contact Person: | Mojca Valjavec |
| Phone: | + 386 1 51 31 506 |
| Fax: | + 386 1 51 31 510 |
| Preparation Date: | 11-28-08 |
II. Device
| Device Trade Name: | Iskra Medical Green IRF Prestige |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulationand Accessories (21 CFR 878.4400) |
III. Legally Marketed Predicate Devices
- . Alma Laser Accent RF System (K070004, K072699)
- . Thermage ThermaCool TC system (K033942, K040135, K053365)
- . Lumenis Aluma Skin Renewal system (K051214)
IV. Device Description
The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
V. Intended Use
The Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
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VI. Rationale for Substantial Equivalence
The Iskra Medical Green IRF Prestige system shares the same indications for use, similar design and functional features with predicate devices, and thus it has been found to be substantially equivalent to the predicate devices.
VII. Summary
As the Iskra Medical Green IRF Prestige system is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate devices, we believe it clearly meets the requirements for substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Iskra Medical, d.o.o. % Ms. Mojca Valjavec Marketing & Sales Manager Stegne 23, SI-1000 Ljubliana SLOVENIA
APR 1 7 2009
Re: K083590
Trade/Device Name: ISKRA MEDICAL GREEN IRF PRESTIGE AND ACCESSORIES Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 18, 2009 Received: March 23, 2009
Dear Ms. Valjavec:
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 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 - Ms. Mojca Valjavec
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) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
Mark N. Melkerson
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IskraMedical
APPENDIX 1
INDICATIONS FOR USE STATEMENT
K 083590 510(k) Number (if known):
Device Name:
ISKRA MEDICAL GREEN IRF PRESTIGE AND ACCESSORIES
Indications for Use:
Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | Page 1 of 1 | |
| Division of General, Restorative, and Neurological Devices | ||
| 510(k) Number | K083590 | |
| Traditional 510(k) Notification: | Appendix 1 |
Iskra Medical Green IRF Prestige and Accessories
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§ 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.