(11 days)
The Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue.
The Applied Medical Laparoscopic Dissector is a sterile, single use, disposable surgical instrument designed for minimally invasive surgical procedures. It fits through a trocar and is used to grasp, mobilize and dissect tissue. The dissector may be connected to a standard electrosurgical generator for performing monopolar cautery. The dissector is substantially equivalent to the predicate device in size, function, performance and indications for use.
The provided text describes a 510(k) premarket notification for a medical device, the Applied Medical Laparoscopic Dissector. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria for specific performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested points regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and MRMC studies are not applicable to this type of document because the review process primarily assesses non-clinical testing and substantial equivalence.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is typically found in device validation reports or clinical study protocols, which are not detailed in this 510(k) summary. The document describes the tests performed but does not provide specific quantitative acceptance criteria or detailed outcomes for each test beyond a general "demonstrated substantial equivalence."
| Test Category | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Dimensional comparison to predicate device | (Implied: Within acceptable manufacturing tolerances and similar to predicate) | Substantially equivalent to predicate device K984240. |
| Dielectric withstand (generator frequency) | (Implied: Meets safety standards for insulation and voltage rating) | Established voltage rating; meets dielectric withstand requirements. |
| Dielectric withstand (mains frequency) | (Implied: Meets safety standards for insulation) | Meets dielectric withstand requirements. |
| Monopolar functionality | (Implied: Effective cauterization) | Functional and equivalent to predicate. |
| Tissue holding, dissecting, piercing, opening | (Implied: Effective and safe handling of tissue) | Effective in these functions, substantially equivalent. |
| Jaw clamping force test | (Implied: Within a specified functional range) | Functional and equivalent to predicate. |
| Thermal safety | (Implied: No excessive heat generation causing harm) | Meets thermal safety requirements. |
| Mechanical abuse | (Implied: Withstands expected forces during use) | Withstands mechanical abuse. |
| Environmental conditioning | (Implied: Maintains integrity after environmental stressors) | Maintains integrity after environmental conditioning. |
Conclusion from Testing: "Applied's performance and functional testing demonstrated that the Applied laparoscopic tissue dissector is substantially equivalent to the predicate device of K984240 and introduces no new safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests submitted. It does not mention a "test set" in the context of patient data or algorithm performance. The tests performed are likely engineering and bench-top tests, for which "sample size" would refer to the number of devices or components tested. This information is not provided in the summary. Data provenance is also not applicable as it refers to clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The tests described are non-clinical (dimensional, electrical, mechanical, thermal), which do not typically involve human expert ground truth establishment in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are non-clinical and do not involve human adjudication of results in the context of clinical outcomes or expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human reader performance is being evaluated with and without AI assistance. This document describes a surgical instrument where the primary evaluation is substantial equivalence through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" would be established by engineering specifications, industry standards, and established metrics for material properties, electrical performance, mechanical strength, and thermal characteristics. For instance, dieletric withstand would be compared against a specific voltage standard, and clamping force against a defined range. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these tests.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K', '1', '0', '3', '2', '8', and '2'. The characters are written in a clear and legible manner.
Image /page/0/Picture/1 description: The image shows the logo for Applied Medical. The logo consists of the word "Applied" in large, bold font, with the word "Medical" underneath in a smaller font. To the right of the text is a triangular graphic with curved lines inside.
510(k) SUMMARY
Page 1 of 2
SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA, 92688 (949) 713-8000
CONTACT PERSON: Frans VandenBroek Principal Specialist, Regulatory Affairs (949) 713-8369 (949) 713-8205 (FAX)
NOV 1 6 2010
DATE OF PREPARATION: August 27, 2010
TRADE NAME: Laparoscopic Dissector
COMMON NAME: Tissue dissector
CLASSIFICATION NAME: Electrosurgical cutting and coagulating device and accessories, class II, CFR 878.4400, product code GEI
PREDICATE DEVICE: K984240, ENDOPATH Endoscopic Instruments
DEVICE DESCRIPTION: The Applied Medical Laparoscopic Dissector is a sterile, single use, disposable surgical instrument designed for minimally invasive surgical procedures. It fits through a trocar and is used to grasp, mobilize and dissect tissue. The dissector may be connected to a standard electrosurgical generator for performing monopolar cautery. The dissector is substantially equivalent to the predicate device in size, function, performance and indications for use.
INTENDED USE: The Applied Medical Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The dissector shares a common design with Applied Medical's laparoscopic graspers and scissors. All are made of various polymers and stainless steel, and all feature a slender shaft with a handle at one end and articulated jaws (or scissor blades) at the tip. The shaft may be rotated 360° for optimum approach to tissue that is to be dissected. The handle is constructed in line with the shaft and is ergonomically shaped to fit the hand of the user. A toggle on the handle closes and opens the jaws. The curved articulated jaws are similar to the jaws of the predicate device.
ﺎ ﻟﻤﻠ
{1}------------------------------------------------
As is the case with the predicate device, the jaws of Applied's dissector may be energized by a standard electrosurgical generator. An accessory cord connects the dissector to the generator which delivers monopolar energy to the jaws for cauterizing tissue.
The Applied laparoscopic dissectors will be manufactured with straight and angled shafts and in two different lengths. Packaging consists of a Tyvek/Mylar peel pouch and a carton. Sterilization is via gamma irradiation; sterility assurance level will be 10-6.
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: Applied Medical created a dedicated test method designed to confirm safety and efficacy of the dissector as well as substantial equivalence relative to the predicate device of K984240. These tests focused on:
- 0 Dimensional comparison to predicate device
- Dielectric withstand (generator frequency) and establishment of voltage rating with the 0 active electrode/insulated shaft
- Dielectric withstand (generator frequency) of device handle .
- o Dielectric withstand (mains frequency)
- o Monopolar functionality
- o Tissue holding, dissecting, piercing and opening
- � Jaw clamping force test
- . Thermal safety
なく
- . Mechanical abuse
- . Environmental conditioning
CONCLUSIONS DRAWN FROM TESTING: Applied's performance and functional testing demonstrated that the Applied laparoscopic tissue dissector is substantially ecouitr to the predicate device of K984240 and introduces no new safety and effectivenery iquival.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three parallel lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Applied Medical Resources Corporation % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747
NUV 16 2010
Re: K103282
Trade/Device Name: Laparoscopic Dissector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 04, 2010 Received: November 05, 2010
Dear Mr. Conry:
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. Or to and Cosmetic Act (Act) that do not 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. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you; however, that device labeling must be truthful and not micleading.
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 devine 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 that FDA has made a determination that your device complies with other requirements of the Act
{3}------------------------------------------------
Page 2 - Mr. Casey Conry
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
cerely yours,
For Dm. Dender
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
NOV 1 6 2010
510(k) Number (if known): Not yet assigned K103282
Device Name: Laparoscopic Dissector
Indications for Use: The Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.S. Jordan for mxm
(Division Sign-(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103282
Attachment I - 1
Page 1 of
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.