(90 days)
Not Found
No
The document describes a physical surgical instrument and its reprocessing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a surgical instrument used for cutting and hemostasis, not a therapeutic device designed to treat a disease or condition.
No
This device is a surgical instrument used for cutting and hemostasis, not for diagnosing conditions or diseases.
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 text, 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 surgical procedures. This is a direct surgical intervention on the body, not a test performed on samples taken from the body.
- Device Description: The description details a surgical instrument used for cutting and hemostasis during surgery. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient during a procedure.
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, LFL
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 reprocessed 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 reprocessed.
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/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Bruce Lester Vice President, Research and Development SterilMed, Inc. 11400 73rd Ave. North Minneapolis, Minnesota 55369
NOV 1 2004
Re: K012571 - Supplemental Validation Submission Trade/Device Name: Reprocessed Ultrasonic Scalpel (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: August 7, 2001 Received: August 9, 2001
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 7, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable 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.
1
Page 2 - Dr. Bruce Lester
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Reprocessed Ultrasonic Scalpel Models found to be Substantially Equivalent:
-
- Ethicon, HDH05
-
- Ethicon, HSH05
- Ethicon, HBC05 3.
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- Ethicon, HC325
-
- Ethicon, DH010
- Ethicon, DSH10 6.
-
- Ethicon, DBC10
- Ethicon, DH105 8.
- Ethicon, DH145 9.
-
- Ethicon, HC105
-
- Ethicon, SH105
-
- Ethicon, SH145
3
Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Harmonic Scalpels
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.
Prescription Use_ × (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)
iriam C. Provost
Division of General, Restorative, and Neurological Devices
Page 1 of _
510(k) Number K012571
4
NOV 0 7 2001
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Patrick Fleischhacker |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | August 7, 2001 |
| Trade Name: | Reprocessed Harmonic Scalpels |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| Accessories | |
| Classification Number: | 21 CFR 878.4400 |
| Product Code: | LFL |
| Predicate Device(s): | The reprocessed harmonic scalpel is substantially |
| equivalent to the Harmonic Scalpel Hs2 Blade (K941897), | |
| manufactured by Ethicon (formerly Ultracision); Reusable | |
| Laparosonic Blade System (K930352), manufactured by | |
| Ethicon (formerly Ultracision); and the counterpart devices | |
| from the original manufacturer. | |
| 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. |
Premarket Notification
.
.
5
The reprocessed harmonic scalpels are intended for use in Intended Use: 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 reprocessed 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 reprocessed.
The reprocessed harmonic scalpel is substantially equivalent to Harmonic Scalpel Hs2 Blade (K941897), manufactured by Ethicon (formerly Ultracision); Reusable Laparosonic Blade System (K930352), manufactured by Ethicon (formerly Ultracision); and the counterpart devices from the original manufacturer. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
Conclusion:
Functional and
Safety Testing: