(120 days)
The Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.
The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down.
The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade.
Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
The provided documentation is a 510(k) Summary for the Vanguard Reprocessed Ultrasonic Scalpel. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a performance study.
Here's what can be inferred from the provided text, and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The "acceptance" for this regulatory submission is demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: The document states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, it does not provide specific performance metrics (e.g., cutting force, coagulation time, re-use cycle durability) or the numerical results of these tests against any pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing: This information is not provided. The document mentions "performance and biocompatibility testing" but offers no details about the sample sizes of devices tested, the type of data collected, or its origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Missing: This is not applicable in the context of this 510(k) submission. The "ground truth" here is typically established through engineering and laboratory testing for reprocessing efficacy and device function, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable for this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No: An MRMC comparative effectiveness study is not relevant to this device. This device is an ultrasonic surgical scalpel, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is not an AI algorithm. It is a reprocessed physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred Ground Truth: For a reprocessed surgical instrument, the "ground truth" would typically involve:
- Cleaning efficacy: Absence of residual biological material (e.g., protein, hemoglobin) after reprocessing, confirmed by laboratory assays.
- Sterilization efficacy: Confirmation of sterility (e.g., sterility assurance level, bacterial endotoxin testing).
- Functional performance: Verification that the reprocessed device performs according to OEM specifications (e.g., cutting ability, coagulation, instrument articulation, electrical isolation) through mechanical and electrical testing.
- Biocompatibility: Confirmation that reprocessing does not introduce cytotoxic or allergenic residues.
- Explicitly Stated: The document refers to "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
8. The sample size for the training set:
- Missing: This document is not about an AI device that would have a training set.
9. How the ground truth for the training set was established:
- Missing: Not applicable as it's not an AI device.
Summary of what the document focuses on:
The entire submission focuses on establishing substantial equivalence to existing, legally marketed ultrasonic scalpels. The core argument for substantial equivalence of the reprocessed device rests on:
- Identical Technological Characteristics: "The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed Ultrasonic Scalpels possess identical technological characteristics."
- Demonstrated Safety and Performance: Through "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."
The 510(k) process for a reprocessed device primarily requires demonstrating that the reprocessing method reliably restores the device to its original performance specifications and that the device remains safe and effective for its intended use, without significantly altering its fundamental technology or indications for use. It does not typically involve the kind of elaborate clinical or AI performance studies requested in the prompt.
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510(k) Summary of Safety & Effectiveness
KO43215
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [voice]863-683-8703 [facsimile]hcrawford@safe-reuse.com [email] |
| Date | November 20, 2004 |
| Device | Trade Name: Vanguard Reprocessed Ultrasonic ScalpelCommon Name: Ultrasonic Surgical Instrument21 CFR Section: UnclassifiedProduct Code: NLQ - Scalpel, Ultrasonic, Reprocessed - Class II |
| PredicateDevices | Trade Names: Ethicon Endo-Surgery UltraCision® Harmonic Scalpel®510(k) numbers: K925699: Ultracision, Inc., Harmonic Scalpel Laparosonic Clamp CoagulatorK980099: Ethicon Endo-Surgery, Inc., UltraCision LaparoSonic Coagulating Shears LCS-5K993054: Ethicon Endo-Surgery, Inc., UltraCision Harmonic Scalpel LCS and CS Curved Shears |
| Indications forUse | The Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required. |
| Contra-indications | This instrument is not intended for contraceptive tubal ligation or for bone excision. |
| Continued on next page |
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510(k) Summary of Safety & Effectiveness, Continued
| DeviceDescription | The Reprocessed Ultrasonic Scalpels are hand held instruments which maybe used to cut and coagulate tissue when connected to a compatibleultrasonic handpiece and generator. Scalpels are 5mm in diameter withfunctional lengths of 14 to 36cm. The instrument jaws are opened and closedusing proximal ring handles, available with a pistol or scissor grip style. Theinstrument tip and shaft can be rotated 360° in either direction using a knobon the handle. Scalpels are available with various blade configurations:curved, blunt, and knife down. |
|---|---|
| The proximal handle is designed for attachment to a compatible handpieceand microprocessor controller. Electrical outputs from the controller areconverted by an ultrasonic transducer within the handpiece to mechanicalvibrations that are transmitted through the instrument shaft to the distalscalpel blade. | |
| Vanguard receives previously used Ultrasonic Scalpels from healthcarefacilities; cleans, inspects, tests, packages, labels, and sterilizes the devices;and returns them to a healthcare facility for subsequent use. | |
| TechnologicalCharacteristics | The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to thecurrently marketed Original Equipment Manufacturer (OEM) devices. Nochanges are made to the device materials or specifications and the reprocessedUltrasonic Scalpels possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion | Based upon the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that VanguardReprocessed Ultrasonic Scalpels are substantially equivalent to their predicatedevices under the Federal Food, Drug and Cosmetic Act. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle, which is a common symbol of the United States.
MAR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815
Re: K043225
K043223
Trade/Device Name: Vanguard Reprocessed Ultrasonic Scalpel Regulatory Class: Unclassified Product Code: NLQ Dated: February 17, 2005 Received: February 18, 2005
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainter institution (for the included in interests a referenced above and nave decemblied the arrest of predicate devices marketed in interstate for use stated in the enclosure to regary manated to the Medical Device Amendments, or to commerce prior to May 28, 1976, the enatified in accordance with Federal Food. Drug.
devices that have been reclassified in accordance with the provision (UMA) devices that have been reclassified in acceraarses whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act - The and Cosment Act (Act) that do not require approvid controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, merefore, market me dovres, basjer to the one of the general controls provisions of the Fiel 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 c If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controllor "Entrolo" of the 800 to 898. In addition, FDA may be found in the Ood of Pourse concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualles of a statually with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that 117A has made a dolorimiation administered by other Federal agencies. You must of any Federal Statutes and regulations and miting, but not limited to: registration and listing (21 comply with an the Act 3 requirements, meteaning, .
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 807). good manart 820); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 1489-1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Heather Crawford, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin hankeling your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial end this permits vo premarket notification. The PDA inding of succlainted by:
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
s and the may be and 15 and be and any and one more the regulation entitled If you desire specific advice ior your ac vice on our same note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation contact the Office of Compliance at (210) 276 - 107 (21CFR Patt 807.97). You may obtain "Misbranding by reference to premation non heat the Act from the Division of Small
other general information on your responsibilities under the Act from worther (800) 633-20) other general information on your responsionnes and its toll-fire number (800) 638-2041 or Manufacturers, Internet and Consulter Assistance at to courted to to courters index.html.
Sincerely yours,
Z. Zohrab
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
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Indications for Use
510(k) Number (if known):
Device Name: Vanguard Reprocessed Ultrasonic Scalpel
Indications for Use:
Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive Reprocessed Ontrasonic Ocalper is intentional for see bagulation and incision of soft tissue is required.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
gn-Off)
General, Restcrative
ological Devices
mber. K043225
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0013
N/A