(87 days)
Not Found
No
The document describes a reprocessed surgical instrument (harmonic scalpel) and its functional testing. There is no mention of AI, ML, or any related computational technologies.
Yes
The device is a surgical instrument used for cutting and coagulating tissue in various medical procedures, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a surgical instrument used for cutting and coagulating tissue (hemostasis), not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical instrument (harmonic scalpel) with a handle, shaft, blade, and clamp arm, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a surgical instrument used for cutting and coagulating soft tissue during surgical procedures. It is used directly on the patient's body.
- Intended Use: The intended use is for surgical procedures, not for analyzing biological samples.
The device is a surgical tool used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The reprocessed harmonic scalpels are indicated to be used for cutting of 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 and endoscopic procedures.
Product codes
NLQ, LFL
Device Description
SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator and torque wrench 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 an 18 cm shaft length, 8.5 mm shaft diameter, active blade length of 18 mm, and utilizes a straight blade and clamp arm. 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
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.
Key Metrics
Not Found
Predicate Device(s)
The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVETM harmonic scalpels.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(K) PREMARKET NOTIFICATION SUBMISSION OCTOBER 10, 2008 For Reprocessed Harmonic Scalpel
SUMMARY AND CERTIFICATION II.
510(k) Summary A.
SterilMed, Inc. Submitter:
Contact Person:
Dennis Toussaint 11400 73rd Avenue North Maple Grove, MN 55369 Ph: 763-488-3410 Fax: 763-488-2051
JAN. - 9 2009
883060
| Date Prepared: | October 10, 2008 |
|---|---|
| Trade Name: | Reprocessed Harmonic Scalpel |
| Classification Name: | Scalpel, Ultrasonic, Reprocessed |
| Classification Number: | Unclassified |
| Product Code: | NLQ |
| Predicate
Devices: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVETM
harmonic scalpels. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator
and torque wrench 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 an 18 cm shaft length, 8.5 mm shaft diameter, active blade length of 18 mm, and
utilizes a straight blade and clamp arm.
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 scalpels are indicated to be used for cutting of 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 and endoscopic 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. |
| Conclusion: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVE™
harmonic scalpels.
This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. % Mr. Dennis Toussaint Director of Regulatory Affairs 11400 73rd Avenue North Maple Grove, Minnesota 55369
Re: K083060
Trade/Device Name: Reprocessed Harmonic Scalpels Regulatory Class: Unclassified Product Code: NLQ, LFL Dated: October 10, 2008 Received: October 14, 2008
Dear Mr. Toussaint:
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.
JAN - 9 2009
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.
2
Page 2 - Mr. Dennis Toussaint
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. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
5 10(k) Number (if known):_ K083060
Device Name: Reprocessed Harmonic Scalpels
Indications for Use:
The reprocessed harmonic scalpels are indicated to be used for cutting of 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 and endoscopic 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)
Mark A. Milliken
(Division Sign-Of (Division Sign-Only Restorative, Division of Generative, Divisionogical Devices
510(k) Number
4
Devices included in this Premarket Notification Submission – 510(k) K083060
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