(182 days)
Not Found
No
The summary describes a standard ultrasonic surgical instrument and does not mention any AI or ML capabilities. The performance studies are focused on reprocessing and basic function, not algorithmic performance.
No.
The device is described as an ultrasonic scalpel used for cutting and coagulating tissue during surgery, which is an interventional/surgical tool rather than a device for treating a therapeutic condition.
No
Explanation: The device is described as a surgical instrument used to cut and coagulate tissue, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a hand-held instrument and part of an ultrasonic surgical system, indicating it is a physical hardware 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 used in "general and endoscopic surgery to cut and coagulate soft tissue." This describes a surgical instrument used directly on a patient's tissue in vivo.
- Device Description: The description reinforces this by stating it's a "hand-held instrument designed to be used as part of an ultrasonic surgical system" that "cut and coagulate tissue." This is a description of a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, the Reprocessed Ultrasonic Scalpels are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
Reprocessed Ultrasonic 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 substitute for electrosurgery, lasers, and steel scalpels in general, abdominal, pediatric, gynecologic and other open and endoscopic procedures.
Reprocessed Ultrasonic Scalpels are indicated in general and endoscopic surgery to cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
Reprocessed Ultrasonic Scalpels are hand-held instruments designed to be used as part of an ultrasonic surgical system. These devices cut and coagulate tissue when attached to the ultrasonic hand piece and electrosurgical generator.
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)
Bench and laboratory tooling performance testing was conducted to demonstrate performance. Tests included:
- Biocompatibility.
- Reprocessing Validation.
- Sterilization Validation.
- Function Tests.
Performance testing demonstrates that Reprocessed Ultrasonic Scalpels 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 date "JUN 6 - 2005" at the top right. Below the date is a handwritten number that appears to be "2043358". The numbers are written in a clear, legible style. The image is a close-up of the text, with a white background.
Image /page/0/Picture/1 description: The image shows the logo for Alliance Medical Corporation. The logo consists of three curved lines above the company name. The lines are thick and black, and they are arranged in a slightly curved shape. The text "ALLIANCE MEDICAL CORPORATION" is written in a serif font, with "ALLIANCE" on the top line and "MEDICAL CORPORATION" on the bottom line.
SECTION B: 510(k) SUMMARY
10232 South 5 1st Street Phoenix, Arizona 85044
TEL 480.763.5300 FAX 480.763.5310 Toll Free 888.888.3433 w.alliance-medical.com
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
| ------------ | ----------------------------------------------------------------------------------- |
|---|
Elizabeth Renken Contact: Requlatory Affairs Specialist (480) 763-5394 (o) (480) 763-5320 (f) erenken@alliance-medical.com
November 15, 2004 Date of preparation:
Trade/Proprietary Name: Reprocessed Ultrasonic Scalpels Name of device: Common or Usual Name: Reprocessed Ultrasonic Scalpels Classification Name: Ultrasonic Surgical Instruments
Predicate device(s):
Ethicon Endo-Surgery (Ultracision) K980099, K993054
Reprocessed Ultrasonic Scalpels are hand-held instruments Device description: designed to be used as part of an ultrasonic surgical system. These devices cut and coagulate tissue when attached to the ultrasonic hand piece and electrosurgical generator.
- Reprocessed Ultrasonic Scalpels are intended for use in soft Intended use: tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, abdominal, pediatric, gynecologic and other open and endoscopic procedures.
The intended use and technological features of the reprocessed Technological devices do not differ from the legally marketed predicate characteristics: device(s). Both the reprocessed device(s) and the predicate device(s) have the same materials and product design. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The technological characteristics of the Reprocessed Ultrasonic Scalpels are the same as those of the legally marketed predicate device(s). In addition, Alliance Medical Corporation's reprocessing of Ultrasonic Scalpels includes
Alliance Medical Corporation Reprocessed Ultrasonic Scalpels Traditional 510(k)
1
removal of adherent visible soil and decontamination. All removal of adnorom visible of and functionally tested prior to packaging, labeling, and sterilization operations. packaging, laboling, and sing was conducted to demonstrate Bench and laboratory tooling ************************************************************************************************************************************************* performanos (Caroly athis included the following tests:
-
Biocompatibility .
Performance data: -
Reprocessing Validation .
-
Sterilization Validation .
-
Function Tests .
Performance testing demonstrates that Reprocessed Ultrasonic Scalpels perform as originally intended.
Alliance Medical Corporation concludes that the modified Conclusion: Alliance Medical Origorutiran onic Scalpels) are safe, effective devices (Neprooosed alon to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 6 - 2005
Ms. Elizabeth Renken Regulatory Affairs Specialist Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K043358
Trade/Device Name: Alliance Medical Corporation Reprocessed Ultrasonic Scalpels (see attached list) Regulatory Class: Unclassified Product Code: NLQ Dated: March 17, 2005 Received: March 18, 2005
Dear Ms. Renken:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for ass sured in the energe, 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. de nees mat have been 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.
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 r lease oe actised that i Drivision that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must of any I ederal sthates as a 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 form in the quant) 37500110 (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Elizabeth Renken
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your of substantial equivalence of your device to a legally premarket notification " " 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 If you desire specific at (240) 276-0115 . Also, please note the regulation entitled, Contact the Orities of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miretimational 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
4
The following Ultrasonic Scalpels are reprocessed by Alliance Medical Corp. K043398
| Manufacturer | Description | Model |
|---|---|---|
| Ethicon Endo-Surgery | Long 5 mm Curved Shears | LCS-C5L |
| Ethicon Endo-Surgery | 5 mm Curved Active Blade | LCS-C5 |
| Ethicon Endo-Surgery | 5 mm Curved Active Blade | LCS-C1 |
| Ethicon Endo-Surgery | 5 mm Knife Down Active Blade | LCS-K5 |
| Ethicon Endo-Surgery | 5 mm Blunt Active Blade | LCS-B5 |
:
:
:
5
2. Indications for Use Statement
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Ultrasonic Scalpels
Indications for Use: Reprocessed Ultrasonic Scalpels are indicated in general and endoscopic surgery to cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns.
Prescription Use
X
(per 21 CFR 801.109)
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign OR)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K043358
Alliance Medical Corporation Reprocessed Ultrasonic Scalpels Traditional 510(k)
13