(303 days)
Not Found
No
The summary describes a reprocessed surgical instrument (harmonic shears) that uses ultrasonic energy for cutting and coagulation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on functional characteristics, cleaning, sterilization, and packaging validation.
No
The device is described for cutting and coagulation of soft tissue, which are surgical procedures, not therapeutic applications.
No
The device is described as a surgical instrument used for cutting and coagulation of soft tissue, not for diagnosis.
No
The device description clearly outlines a physical instrument (harmonic shears) used in combination with hardware components (handpiece, generator, torque wrench). The performance studies focus on physical characteristics and processes like cleaning, sterilization, and functional bench testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the device is used for "cutting soft tissue" and "coagulation of soft tissue" during surgical procedures. This is a direct interaction with the patient's body during a procedure, not an examination of a specimen outside the body.
- Intended Use: The intended use is for surgical procedures as an alternative or adjunct to other surgical tools. This is a therapeutic or procedural use, not a diagnostic one based on analyzing specimens.
The device is a surgical instrument used on the patient, not a tool for analyzing samples from the patient.
N/A
Intended Use / Indications for Use
The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as un udjunct to or a substitute for clectrosurgery, lasers, and steel scalpels in general, plastic, pediatic, gyncoologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intended to be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. The instruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuated with a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation or with an optional generator foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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)
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO10993), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection. fatigue testing, and function testing. Performance testing shows the reprocessed harmonic shears to perform as originally intended.
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/0 description: The image shows the word "STERILMED" in a simple, sans-serif font. The letters are evenly spaced and appear to be in black or a dark color against a white background. To the left of the word is a small, abstract graphic that is difficult to discern.
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II. SUMMARY AND CERTIFICATION
| A. | 510(k) Summary | K132566 | JUN 14 2014 | |
|---|---|---|---|---|
| Submitter: | Sterilmed, Inc. | |||
| Contact Person: | Jason Skramsted | |||
| 11400 73rd Avenue North | ||||
| Maple Grove, MN 55369 | ||||
| Phone: 763-488-3483 | ||||
| Fax: 763-488-4491 | ||||
| Date Prepared: | 14 August 2013 | |||
| Trade Name: | Reprocessed Harmonic Shears | |||
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed | |||
| Device Classification: | Unclassified | |||
| Product Code: | NLQ |
| Predicate
Devices: | The reprocessed harmonic shears are substantially equivalent to the Ethicon Harmonic Shears (K121550,
K120729 and K060245). |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intended
to be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. The
instruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instruments
allow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuated
with a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation or
with an optional generator foot switch. |
| Intended Use: | The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding
and minimal thermal injury is desired. The instruments can be used as an adjunct to or a substitute for
electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,
exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. |
| Technological
Characteristics: | The reprocessed harmonic shears are identical to the predicate devices in design, materials of construction,
and intended use. There are no changes to the clinical applications, patient population, performance
specifications, or method of operation. |
| Functional and
Safety Testing: | Representative samples of reprocessed harmonic shears 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 (ISO10993), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980). In addition,
validation of functional performance (bench testing) was performed through simulated use, visual inspection.
fatigue testing, and function testing. Performance testing shows the reprocessed harmonic shears to perform
as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed harmonic shears are safe, effective, and substantially equivalent to
the predicate devices, Ethicon Harmonic Shears (K121550, K120729, and K060245), as described in this
premarket notification submission. |
ر
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2014
SterilMed % Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73td Avenue, North Maple Grove, Minnesota 55369
Re: K132566
Trade/Device Name: Reprocessed Harmonic Shears (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: May 20, 2014 Received: May 21, 2014
Dear Mr. Skramsted:
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 Régister.
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 – Mr. Jason Skramsted
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Mr. Jason Skramsted
| Model Number | Device Name | Shaft
Diameter | Shaft
Length |
|--------------|-----------------------------|-------------------|-----------------|
| HAR23M | Reprocessed Harmonic Shears | 5 mm | 23 cm |
| HAR36M | Reprocessed Harmonic Shears | 5 mm | 36 cm |
| ACE23E | Reprocessed Harmonic Shears | 5 mm | 23 cm |
| ACE36E | Reprocessed Harmonic Shears | 5 mm | 36 cm |
| N/A | Reprocessed Torque Wrench | N/A | N/A |
: 上一篇:
:
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Image /page/4/Picture/0 description: The image shows the word "STERILMED" in a simple, sans-serif font. To the left of the word is a stylized graphic, possibly representing a medical symbol or logo. The text and graphic are in black against a white background, creating a clear contrast.
Indications for Use
510(k) Number (if known): K132566
Device Name: Reprocessed Harmonic Shears
Indications for Use:
The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as un udjunct to or a substitute for clectrosurgery, lasers, and steel scalpels in general, plastic, pediatic, gyncoologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Prescription Use X (Part 2) 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)