(182 days)
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.
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.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Reprocessed Ultrasonic Scalpels by Alliance Medical Corporation
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance and Evidence |
|---|---|
| Safety: | |
| - Biocompatibility (no adverse biological reactions) | Bench and laboratory testing included "Biocompatibility" |
| - Freedom from contamination (adequate reprocessing) | Bench and laboratory testing included "Reprocessing Validation" and "Sterilization Validation." The description states, "All removal of adnorom visible of and functionally tested prior to packaging, labeling, and sterilization operations." (Likely a typo and should refer to "removal of adherent visible soil"). This implies testing confirmed effectiveness of cleaning and sterilization processes. |
| - Minimal thermal injury | The intended use states: "cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns." The document asserts "Reprocessed Ultrasonic Scalpels perform as originally intended" (which includes minimal thermal injury as per the original device's claims). No direct test result for thermal injury is provided beyond this assertion. |
| Effectiveness/Performance: | |
| - Function as originally intended (cut and coagulate tissue) | Bench and laboratory testing included "Function Tests." The conclusion states, "Performance testing demonstrates that Reprocessed Ultrasonic Scalpels perform as originally intended." The reprocessing process includes ensuring devices are "functionally tested prior to packaging, labeling, and sterilization operations." The claim is that the reprocessed devices "do not differ from the legally marketed predicate device(s)" in technological features, performance specifications, and method of operation. |
| - Equivalence to predicate device for stated indications | The core argument for 510(k) clearance is "substantial equivalence" to predicate devices (Ethicon Endo-Surgery Ultrasonic Scalpels K980099, K993054). The submission states, "The intended use and technological features of the reprocessed devices do not differ from the legally marketed predicate 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." |
2. Sample Size and Data Provenance for Test Set
- Test Set Description: The document refers to "Bench and laboratory testing" and "Performance testing." It lists categories of tests: Biocompatibility, Reprocessing Validation, Sterilization Validation, and Function Tests.
- Sample Size: The document does not specify the exact sample size for each test category. It generally refers to "tooling" and "testing."
- Data Provenance: The testing was conducted by Alliance Medical Corporation through "Bench and laboratory tooling." No information is given about external collaborators or country of origin other than the company's location in Phoenix, Arizona, USA. The nature of these tests suggests they are internal, prospective studies conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- The document does not indicate the involvement of external experts or a formal "ground truth" establishment process by experts for the performance testing.
- The tests described are primarily engineering and laboratory-based, comparing the reprocessed device to its original specifications or known predicate characteristics. Decisions about "performance as originally intended" would likely be made by R&D engineers and quality assurance specialists within Alliance Medical Corporation, based on pre-defined criteria derived from the original device's specifications.
4. Adjudication Method for Test Set
- There is no mention of an adjudication method (like 2+1 or 3+1) for the test set. Given the nature of the bench and laboratory tests (e.g., sterilization validation, function tests), these typically involve objective measurements against pass/fail criteria rather than expert review and adjudication of subjective outputs.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a medical instrument (ultrasonic scalpel), not an imaging or diagnostic AI-powered device that would typically involve human-in-the-loop performance studies. The 510(k) submission focuses on demonstrating that the reprocessed device performs identically to its predicate.
6. Standalone (Algorithm Only) Performance
- Not applicable. This device is a physical surgical instrument; it does not involve algorithms or AI in its direct operation. Performance is assessed based on its physical characteristics and functional capabilities after reprocessing.
7. Type of Ground Truth Used
- The "ground truth" for the performance testing is implicitly the original design specifications and performance characteristics of the predicate (new) device. The testing aims to confirm that the reprocessed device meets or equals these established benchmarks.
- Biocompatibility: Likely against established ISO standards for medical devices.
- Reprocessing Validation: Against parameters proven to remove contaminants.
- Sterilization Validation: Against established sterilization sterility assurance levels (e.g., SAL of 10^-6).
- Function Tests: Against the functional capability of a new, unused ultrasonic scalpel (e.g., cutting efficacy, coagulation performance, tip integrity).
8. Sample Size for the Training Set
- Not applicable. This is a reprocessed physical device, not a machine learning or AI algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth for it to be established.
{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 Corporation10232 South 51st StreetPhoenix, 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
N/A