(375 days)
Not Found
No
The document describes a reprocessed surgical device and its performance testing, with no mention of AI or ML capabilities.
No
This device is a surgical instrument used for incisions and is not described as providing therapy or treatment for a disease or condition.
No
This device is described as an instrument for soft-tissue incisions and appears to be a surgical tool rather than a device for diagnosing medical conditions. The "Intended Use / Indications for Use" section focuses on its surgical application (cutting and coagulating tissue) and makes no mention of diagnostic capabilities.
No
The device is a reprocessed surgical instrument (Harmonic FOCUS Curved Shears) and is clearly described as a physical device that undergoes cleaning, refurbishment, testing, and sterilization. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting and coagulating soft tissue within the body during various surgical procedures. This is an in vivo application.
- Device Description: The description details a surgical instrument that is reprocessed for clinical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these samples.
Therefore, based on the provided information, the MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft-tissue, otorhinolaryngologic (ear, nose and throat [ENT]), orthopedic structures (such as spine and joint space)
Indicated Patient Age Range
Not Found
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)
The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the below tests: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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.
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510(k) 124033 MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9
K124033
Section 5: 510(K) Summary
| Submitter/
Owner | MEDISISS
2747 SW 6th St.
Redmond, OR 97756 | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Name | Brandi Panteleon
Director of Product Development
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medisiss.com | | |
| Date Prepared | December 26, 2012 | | |
| Device Names | Proprietary Name: MEDISISS Reprocessed Harmonic FOCUS
Curved Shears FCS9
Common Name: scalpel, ultrasonic, reprocessed | | |
| Classification | Scalpel, Ultrasonic, Reprocessed, Unclassified, product code NLQ | | |
| Predicate
Devices | K100597 Ethicon Endo-Surgery Harmonic FOCUS Shears
K063192 Ethicon Endo-Surgery Harmonic FOCUS Shears | | |
| Device
Description | 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. | | |
| Intended 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 (ear, nose and throat
[ENT]), plastic, pediatric, gynecologic, urologic, exposure to
orthopedic structures (such as spine and joint space), and other
open procedures. | | |
| Technological
Characteristics | The technological characteristics of the subject device are
substantially equivalent to the predicate device listed in this
submission. The subject device has the same functionality and
indications 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 been
evaluated and found to be substantially equivalent to the predicate
device based on the below tests: |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Testing | 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, technological
characteristics, and performance data to the predicate device, the
MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9
are 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 |