(198 days)
Not Found
No
The summary describes a reprocessed surgical instrument (harmonic scalpel) and its intended use and testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on functional characteristics, cleaning, sterilization, and biocompatibility, not algorithmic performance.
Yes
The device is indicated for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired, which are therapeutic actions. It performs actions like cutting and coagulation of vessels and tissue to achieve a medical benefit.
No
The device description and intended use clearly state that the harmonic scalpel is used for cutting soft tissue and providing hemostasis, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a reprocessed harmonic scalpel, which is a physical surgical instrument used for cutting and coagulation. It is used in combination with other hardware components like a hand piece and generator.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting soft tissue and providing hemostasis" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical instrument used in combination with other equipment for cutting and coagulating tissue and vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.
The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Product codes
NLO, NLQ
Device Description
SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal, pediatric, gynecologic, 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
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use on beef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), and function testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels to perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
II. SUMMARY AND CERTIFICATION
| SUMMARY AND CERTIFICATION | JAN 11 2012 | ||
|---|---|---|---|
| A. | 510(k) Summary | K111794 | |
| Submitter: | SterilMed, Inc. | ||
| Contact Person: | Onya Dendinger | ||
| 11400 73rd Avenue North | |||
| Maple Grove, MN 55369 | |||
| Ph: 763-488-3410 | |||
| Fax: 763-488-2051 | |||
| Date Prepared: | June 24, 2011 | ||
| Trade Name: | Reprocessed Harmonic Scalpel | ||
| Classification Name: | Scalpel, Ultrasonic, Reprocessed | ||
| Classification Number: | Unclassified | ||
| Product Code: | NLO |
| Predicate
Devices: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears
(510(k) K063192). |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench
and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of
vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and
MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when
closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and
utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and
including 5 mm in diameter.
Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission. |
| Intended
Use: | The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting
soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.
The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in
abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other
open procedures. |
| Functional
and Safety
Testing: | Representative samples of reprocessed harmonic scalpels were tested to demonstrate appropriate functional
characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as
well as device packaging. In addition, the manufacturing process includes visual and validated functional testing
of all products produced. |
| Summary of
Non-clinical
Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP
), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-
07). In addition, validation of functional performance (bench testing) was performed through simulated use on
beef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), and
function testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels to
perform as intended. |
| Conclusion: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears.
This conclusion is based upon the devices' similarities in functional design (principles of operation), materials,
indications for use and methods of construction. |
:
/%
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 1 2012
SterilMed, Inc. % Ms. Onya Dendinger 11400 73td Avenue North Maple Grove, Minnesota 55369
Re: K111794
Trade/Device Name: Reprocessed Harmonic Scalpel Regulatory Class: Unclassified Product Code: NLQ Dated: December 29, 2011 Received: December 30, 2011
Dear Ms. Dendinger:
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 (reporting of medical
2
Page 2 – Ms. Onya Dendinger
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
Indications for Use
KIII 794 510(k) Number (if known):
Device Name: Reprocessed Harmonic Scalpel
Indications for Use:
The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.
The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
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)
NeYfRPOylm for mkm
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111794