(60 days)
Not Found
No
The description focuses on the mechanical and material aspects of a surgical scalpel and its reprocessing. There is no mention of AI, ML, or any computational processing of data for decision-making or analysis.
No.
The device is a surgical instrument used for cutting and hemostasis during soft tissue incisions, not a device directly used for therapy.
No
Explanation: The device description states that harmonic scalpels are intended for use in soft tissue surgery for simultaneous cutting and hemostasis, and are used as an adjunct to or a substitute for other surgical tools. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly outlines physical components like a generator/foot switch, handle, connecting hose, and scalpel blade, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue incisions" and "used in soft tissue surgery." This describes a surgical instrument used directly on a patient's body.
- Device Description: The description details a surgical tool (scalpel blade, handle) that is part of an ultrasonic system for cutting and hemostasis during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health, diagnose conditions, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
Harmonic scalpels are part of an ultrasonic system and are intended to be used in soft tissue surgery for simultaneous cutting and hemostasis. The system consists of a generator/foot switch, handle, connecting hose, and a scalpel blade. Only the handle and scalpel blade are reprocessed. The generator/foot switch and hose components of the device are not included as part of this submission.
Harmonic scalpels can be manufactured using aluminum with a nickel chrome alloy edge or a titanium alloy (with or without a coating). These scalpels are available in a variety of lengths, outer circumferences, angles and sharpness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Representative samples of harmonic scalpels underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
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.
Harmonic Scalpel Hs2 Blade (K941897), Reusable Laparosonic Blade System (K930352)
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/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the largest and the third profile being the smallest. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the image.
JUN 2 - 2005
Food and Drug Administration 9200 CorporateBoulevard Rockville MD 20850
Dr. Bruce R. Lester Vice President, Research and Development SterilMed Incorporated 11400 73td Avenue North Minneapolis, Minnesota 55369
Re: K050343
Trade/Device Name: Reprocessed Ultrasonic Scalpel (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: April 12, 2005 Received: April 12,2005
Dear Dr. Lester:
This letter corrects our substantially equivalent letter of April 12, 2005 regarding the omission of a list of the cleared reprocessed ultrasonic scalpel models.
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 (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.
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.
1
Page 2 - Bruce R. Lester, Ph.D.
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 (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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http:Nwww.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. A. F.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 3 – Bruce R. Lester, Ph.D.
Reprocessed Ultrasonic Scalpel Models found to be Substantially Equivalent:
-
- Ethicon, LCS15
-
- Ethicon, LCS16
-
- Ethicon, LCS1S
-
- Ethicon, LCS6S
-
- Ethicon, CS150
-
- Ethicon, CS151
-
- Ethicon, CS1S
-
- Ethicon, CS6S
3
APR 12 2005
K050343 (pg 1 of 2)
SECTION 2. SUMMARY AND CERTIFICATION
2.A. 510(K) SUMMARY
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. Lester |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | February 9, 2005 |
| Trade Name: | Reprocessed Harmonic Scalpels |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NLQ |
| Predicate Device(s): | The reprocessed harmonic scalpels are substantially |
| equivalent to Harmonic Scalpel Hs2 Blade (K941897), | |
| manufactured by Ethicon (formerly Ultracision) and | |
| Reusable Laparosonic Blade System (K930352), | |
| manufactured by Ethicon (formerly Ultracision). | |
| Device Description: | Harmonic scalpels are part of an ultrasonic system and are |
| intended to be used in soft tissue surgery for simultaneous | |
| cutting and hemostasis. The system consists of a | |
| generator/foot switch, handle, connecting hose, and a | |
| scalpel blade. Only the handle and scalpel blade are | |
| reprocessed. The generator/foot switch and hose | |
| components of the device are not included as part of this | |
| submission. |
Harmonic scalpels can be manufactured using aluminum
with a nickel chrome alloy edge or a titanium alloy (with or
without a coating). These scalpels are available in a variety
of lengths, outer circumferences, angles and sharpness. |
4
K050343 (pg 2 of 2)
Intended Use:
Functional and
Safety Testing:
The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Representative samples of harmonic scalpels underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
The harmonic scalpels reprocessed by SterilMed are substantially equivalent to the following specific predicate devices: Harmonic Scalpel Hs2 Blade (K941897), manufactured by Ethicon (formerly Ultracision) and Reusable Laparosonic Blade System (K930352), manufactured by Ethicon (formerly Ultracision). This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
Conclusion: