(86 days)
The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
The Genesis is an instrument intended for use as a monopolar electrosurgical accessory. The device reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use. Genesis devices are intended for use with monopolar electrosurgical accessories and will be packaged separately. Genesis instruments will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
This document is a 510(k) summary for a medical device called "Genesis" from MEDISISS. It details the device's classification, indications for use, and a comparison to predicate devices, but lacks the specific performance data needed to populate all sections of your request.
Here's what can be extracted from the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance
According to the provided text, the Genesis device is an electrosurgical accessory. The acceptance criteria and reported device performance would typically include quantifiable metrics related to its stated features: "reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use."
However, this document does not contain a table of acceptance criteria or reported device performance with specific numerical values for these claims. The 510(k) summary itself focuses on establishing substantial equivalence to predicate devices, not on providing detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document describes the device and its indications but does not mention any specific studies, test sets, sample sizes, or data provenance.
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 available in the provided text. There is no mention of an expert panel or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not available in the provided text. No adjudication method is described as no test set data is provided.
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. The Genesis is an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Genesis is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not available/Applicable in the provided text. As this is an electrosurgical accessory, the "ground truth" would likely relate to the physical effects of its operation (e.g., smoke reduction, tissue damage, eschar accumulation), which would be assessed directly during testing, not established through expert consensus or pathology in the same way a diagnostic device would. However, the specific methods are not described.
8. The sample size for the training set
Not applicable. The Genesis is a physical electrosurgical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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510(K) Summary of Safety & Effectiveness
AUG 2 8 2008
| Submitted By | MEDISISS2747 SW 6th St.Redmond, OR 97756 | |
|---|---|---|
| Contact Names | Brandi JamesDirector, Technical ServicesP: 541-923-3310F: 541-923-3375E: bjames@medisiss.com | |
| Submission Date | June 2, 2008 | |
| Proprietary Device Name | GenesisTM | |
| Classification | Electrosurgical Electrodes, Class II, Electrosurgical cutting andcoagulation device and accessories, General and plastic surgery (21 CFR878.4400), GEI | |
| Predicate Devices | Valleylab Uncoated Electrosurgical Blade (E1551X)(Preamendment)Valleylab EDGETM Coated Electrosurgical Blade ( E1450X):Conmed Coated Electrosurgical Blade (139100)Megadyne Coated Eelectrosurgical Blade (0012)Surginetics AdvantageBlade Electrosurgical BladeMyco Medical Surgical Blades (non-electrosurgical) | K962044K991855K913473K062350Exempt |
| Indications for Use | The Genesis is indicated for use in surgical procedures (generalneurosurgical, laparoscopic, orthopedic, gynecologic, etc.) wheremonopolar electrosurgical cutting and coagulation are normallyused. The Genesis instruments are an alternative to conventionalmonopolar electrosurgical electrodes used for these indications. | |
| Product Description | The Genesis is an instrument intended for use as a monopolarelectrosurgical accessory. The device reduces the smoke emitted intothe surgical area, uses lower power with less tissue damage and theouter layer provides a surface that reduces tissue accumulations andfacilitates removing tissue residues, such as eschar, that mayaccumulate during use.Genesis devices are intended for use with monopolar electrosurgicalaccessories and will be packaged separately. Genesis instrumentswill also fit in currently marketed electrosurgical pencils offered byother manufacturers. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
MEDISISS % Ms. Brandi James Director, Technical Services 2747 SW 6th Street Redmond, Oregon 97756
Re: K081559
·
Trade/Device Name: Genesis Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 5, 2008 Received: August 5, 2008
Dear Ms. James:
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 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 - Mc. Brandi James
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) 276-0115. 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 Biometric'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 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.
Mark M. Millerson
- 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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4. Indications for Use
510(k) Number (if known): Not assigned at this time.
Device Name: Genesis
Indications For Use:
The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrodes used for these indications.
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) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K081559 |
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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.