(11 days)
Not Found
No
The document describes a mechanical surgical device (trocar system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a trocar system used to establish a path of entry for endoscopic instruments, which is a surgical tool, not a therapeutic device. Its function is to create access for other instruments, not to treat a disease or condition itself.
No
Explanation: The device, the Applied Medical Modular Trocar System, is intended for establishing a path of entry for endoscopic instruments during minimally invasive surgical procedures or gaining access through tissue planes. Its function is to facilitate access for other instruments, not to diagnose medical conditions by identifying diseases or conditions through analysis of data, images, or direct observation.
No
The device description clearly states it is a "sterile single use device" and describes physical components like obturators, seals, and cannulas, indicating it is a hardware 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 describes the device as being used to establish a path of entry for endoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body).
- Device Description: The description details the physical components of a trocar system (obturator, seal, cannula) and its sizes and lengths. These are physical instruments for surgical access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to facilitate surgical procedures.
N/A
Intended Use / Indications for Use
The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to qain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular System may be used with an Optical Separator and may be used with or without visualization for primary and secondary insertions.
The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold® cannula and is intended for use in coniunction with Applied's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
The Modular Trocar System will be available in sizes of 5mm, 11mm, 12 mm and 15mm diameter in lengths ranging from 55mm to 150mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The performance and functional testing of the Modular Trocar System included tests to verify the inflation and leakage as compared to its predicate devices. The performance and functional testing demonstrated that the Modular Trocar System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
JAN 2 4 2006
K 060096
510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 22872 Avenida Empresa | |
| Rancho Santa Margarita, CA-92688 | |
| (949) 713-8000 | |
| CONTACT PERSON: | Cheryl Blake |
| Vice President, Regulatory Affairs and Quality | |
| Systems | |
| DATE OF PREPARATION: | December 21, 2005 |
| NAME OF DEVICE: | Modular Trocar System |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR |
| 876.1500) | |
| TRADE NAME: | Modular Trocar System |
| PREDICATE DEVICE: | Applied Medical Modular Trocar (K932995) |
| Applied Medical Optical Separator (K032889) | |
| Applied Medical, Rancho Santa Margarita, CA |
INTENDED USE: The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to qain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular System may be used with an Optical Separator and may be used with or without visualization for primary and secondary insertions.
DEVICE DESCRIPTION: The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
The Modular Trocar System will be available in sizes of 5mm, 11mm, 12 mm and 15mm diameter in lengths ranging from 55mm to 150mm.
1
PERFORMANCE DATA SUMMARY: The performance and functional testing of the Modular Trocar System included tests to verify the inflation and leakage as compared to its predicate devices. The performance and functional testing demonstrated that the Modular Trocar System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.
2
Third Party Review Quality Assessment
| Section 1 – Submission Information |
|---|
| ------------------------------------ |
| 510(k) No.: | K060096 | Third Party Organization: | UL |
|---|---|---|---|
| Third Party's Primary Reviewer(s): | Morten Christensen | ||
| ODE/OIVD Division: | DGRND | Branch/Team: | GSDB |
| Section 2 – 510(k) Decision |
|---|
| ----------------------------- |
| Third party recommendation: | SE ✓ NSE Other (specify): | Other (specify): | |
|---|---|---|---|
| ODE/OIVD final decision: | SE ✓ NSE Other (specify): | Other (specify): |
| Section 3 – Assessment of Third Party Review |
|---|
| ---------------------------------------------- |
| Review Element | Rating (check one) | ||
|---|---|---|---|
| Adequate | Minor Issue(s) | Major Issue(s) | |
| a. Determination of device eligibility for third party review | ✓ | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | ✓ | ||
| c. Organization and format of review documentation | ✓ | ||
| d. Determination of 510(k) administrative completeness (screening review) | ✓ | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | ✓ | ||
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | ✓ | ||
| g. Rationale for conclusions and recommendation | ✓ | ||
| h. Use of guidance documents and standards | ✓ | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | ✓ |
Comments (explanation of ratings/issues):
k. Other (specify):
j. Scope of reviewer expertise and use of consulting reviewers
Section 4 – ODE/OIVD Assessor/Information
| Labels | Values |
|---|---|
| Assessed by: | illegible |
| Date: | 1/23/06 |
| Tel. No.: | 4-130.7. ×192 |
سمل
Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). DMC--Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes emanating from its head, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
Applied Medical Resources c/o Mr. Morten Simon Christensen Staff Engineer and FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road San Jose, California 95131-1230
Re: K060096
Trade/Device Name: Modular Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 12, 2006 Received: January 13, 2006
Dear Mr. Christensen:
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, Drug, 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. Iisting 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 cquivalence determination does not mcan that FDA has made a determination that your device complies 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Christensen
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Barbara Buckner
Mark N. Melk Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K 060096
Device Name:
Indications for Use:
The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold® cannula and is intended for use in coniunction with Applied's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Obarbare Bucknum An MPA Page 1 of 1
Division Sign off
Division of Genera'. Restorative, and Neurological Devices
510(k) Number K060096
510(k) - ODE/FDA Modular Trocar System December 2005