(375 days)
The MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 (originally manufactured by Ethicon Endo-Surgery). Following clinical use, the instruments are cleaned, refurbished, tested, inspected, packaged, sterilized with ethylene oxide and returned to the user facility by MEDISISS for an additional clinical use.
This document, K124033, describes a 510(k) premarket notification for the MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9. This is a reprocessing submission, meaning the device is a reprocessed version of an existing device (Ethicon Endo-Surgery Harmonic FOCUS Shears).
The acceptance criteria and the study proving the device meets them are described in terms of "Performance Testing" to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (as stated in the document) |
|---|---|
| Grasping/Pull Force | Evaluated and found substantially equivalent |
| Cutting Effectiveness / Functionality | Evaluated and found substantially equivalent |
| Drop Test | Evaluated and found substantially equivalent |
| Device Integrity | Evaluated and found substantially equivalent |
| Cutting/Coagulation Evaluation for a Prolonged Period of Time | Evaluated and found substantially equivalent |
| Thermal Analysis Characterization | Evaluated and found substantially equivalent |
| Tissue Sticking: Simulated Use | Evaluated and found substantially equivalent |
| IEC 60601-1 (Electrical Safety Standard) | Evaluated and found substantially equivalent |
| Cleaning (o protein, carbohydrate, hemoglobin, and endotoxins) | Evaluated and found substantially equivalent |
| Biocompatibility (o cytotoxicity, sensitization, irritation, and acute systemic toxicity) | Evaluated and found substantially equivalent |
| Performance Qualification | Evaluated and found substantially equivalent |
| Sterilization and Stability | Evaluated and found substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device is reprocessed and returned to the user facility, implying data would be generated from testing reprocessed units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies listed are likely laboratory-based performance tests rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The performance tests described do not suggest a need for an adjudication method in the context of human expert review.
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
This information is not applicable. The device is a surgical instrument (reprocessed shears), not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical surgical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used
For performance testing (e.g., cutting effectiveness, pull force, thermal analysis), the "ground truth" would be established by objective measurements against predefined engineering specifications and criteria, ensuring the reprocessed device performs comparably to the original predicate device. For biocompatibility and cleaning, the ground truth would be established by laboratory analyses (e.g., measuring residual protein/endotoxins) against established safety limits. The document does not explicitly state the specific thresholds or methodologies for these "ground truths," only that evaluation led to a conclusion of substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable/not provided. Since this is a physical medical device (reprocessed surgical tool) and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The "training" for the reprocessing process would involve establishing and validating the cleaning, refurbishment, and sterilization protocols, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as there is no "training set" for an algorithm. For the reprocessing methods, the "ground truth" for validating the cleaning, refurbishment, and sterilization processes would be established through scientific evidence and adherence to recognized standards (e.g., AAMI standards for sterilization, FDA guidance for reprocessing), demonstrating that the reprocessed device meets the same safety and performance requirements as a new device.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the word "MEDISISS" in black font. To the left of the word is a graphic of lines radiating outward, resembling a sun or starburst. A trademark symbol is located to the upper right of the word.
(i
it
510(k) 124033 MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9
K124033
Section 5: 510(K) Summary
| Submitter/Owner | MEDISISS2747 SW 6th St.Redmond, OR 97756 | ||
|---|---|---|---|
| Contact Name | Brandi PanteleonDirector of Product DevelopmentP: 541-923-3310F: 541-923-3375E: bpanteleon@medisiss.com | ||
| Date Prepared | December 26, 2012 | ||
| Device Names | Proprietary Name: MEDISISS Reprocessed Harmonic FOCUSCurved Shears FCS9Common Name: scalpel, ultrasonic, reprocessed | ||
| Classification | Scalpel, Ultrasonic, Reprocessed, Unclassified, product code NLQ | ||
| PredicateDevices | K100597 Ethicon Endo-Surgery Harmonic FOCUS ShearsK063192 Ethicon Endo-Surgery Harmonic FOCUS Shears | ||
| DeviceDescription | MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9(originally manufactured by Ethicon Endo-Surgery). Followingclinical use, the instruments are cleaned, refurbished, tested,inspected, packaged, sterilized with ethylene oxide and returned tothe user facility by MEDISISS for an additional clinical use. | ||
| Intended Use | The MEDISISS Reprocessed Harmonic FOCUS Curved ShearsFCS9 is indicated for soft-tissue incisions when bleeding controland minimal thermal injury are desired. The instrument can be usedas an adjunct to, or substitute for, electrosurgery, lasers, and steelscalpels in general, otorhinolaryngologic (ear, nose and throat[ENT]), plastic, pediatric, gynecologic, urologic, exposure toorthopedic structures (such as spine and joint space), and otheropen procedures. | ||
| TechnologicalCharacteristics | The technological characteristics of the subject device aresubstantially equivalent to the predicate device listed in thissubmission. The subject device has the same functionality andindications as the predicate device. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the word "MEDISISS" in bold, black letters. To the left of the word, there is a graphic of lines radiating outward, resembling a sun or starburst. The word appears to be a logo or brand name.
.
510(k) 124033 Reprocessed Harmonic FOCUS Curved Shears FCS9
| The functional characteristics of the subject device have beenevaluated and found to be substantially equivalent to the predicatedevice based on the below tests: | |
|---|---|
| PerformanceTesting | grasping/pull force; cutting effectiveness /functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking: simulated use; IEC 60601-1; cleaning; o protein, carbohydrate, hemoglobin, and endotoxins; biocompatibility; o cytotoxicity, sensitization, irritation, and acute systemic toxicity; performance qualification; sterilization and stability. |
| Conclusion | Based on a comparison of the Indications for Use, technologicalcharacteristics, and performance data to the predicate device, theMEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9are substantially equivalent to the predicate devices. |
.
ﺗﻬ
ﺗ
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird-like figure with three wing-like extensions.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MEDISISS
Ms. Brandi Panteleon Director, Product Development 2747 Southwest 6th Street Redmond, Oregon 97756
January 7, 2014
Re: K124033
Trade/Device Name: MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 Regulatory Class: Unclassified Product Code: NLQ Dated: December 20, 2013 Received: December 26, 2013
Dear Ms. Panteleon:
We have reviewed vour 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 (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.
{3}------------------------------------------------
Page 2 - Ms. Brandi Panteleon
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/ResourcesforYou/Industry/default.htm. 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 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.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "MEDISISS" in bold, black letters. There are small lines radiating outwards from the left side of the word, giving the impression of light or energy. The font is simple and sans-serif, and the overall design is clean and modern. The word appears to be a brand name or logo.
510(k) 124033 MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9
.
Section 4: Indications for Use
510(k) Number: FBD K124033
Device Name: MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9
Indications for Use:
The MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109)
(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)
| Long H.Chen -A | Digitally signed by Long H. Chen-A ON: c=US, o=U.S. Government ou=HHS, ou=FDA ou=People, cn=Long H Chen-A 0.9.2342.19200300.100.1.1-1.300369056 Date: 2014.01.01 15:02:18 -05'00' | for BSA |
|---|---|---|
| (Division Sign-off) | ||
| Division of Surgical Devices | ||
| 510(k) Number: | K124033 |
N/A