(74 days)
The Optical Separator 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 gain access through tissue planes and/or potential spaces for endoscopic instruments. The Optical Separator System may be used with or without visualization for primary and secondary insertions, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
The Optical Separator System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
The Optical Separator 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. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Dilating Tip Trocar dilates and separates tissue along its natural fiber lines in its path of entry.
The Optical Separator System will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.
The provided document is a 510(k) summary for the Optical Separator System. It describes the device, its intended use, and states that performance testing demonstrated substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for a comprehensive table as requested.
The document states: "The performance and functional testing of the Optical Separator System included tests to verify the insertion force and tests to verify its reliability and visualization during use. The performance and functional testing demonstrated that the Optical Separator System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This is a general statement and does not provide quantifiable acceptance criteria or detailed results.
Therefore, many of the requested fields cannot be filled from the provided text.
Here’s what information can be extracted/inferred:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General | Substantially equivalent to predicate devices (Applied Medical Optical Separator K032889 and Insufflation Needle K963359) |
| Insertion Force | Tested and verified |
| Reliability | Tested and verified |
| Visualization during use | Tested and verified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (likely internal company testing, but no details on country or whether it was retrospective/prospective).
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)
- Not applicable. This device is a surgical instrument, not an AI/diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "performance data" refers to functional and reliability testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and testing.
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
- Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Performance testing for this device would involve engineering benchmarks, material specifications, and functional testing rather than clinical ground truth for diagnosis/interpretation.
8. The sample size for the training set
- Not applicable. This is a physical surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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SEP 1 4 2004
510(k) SUMMARY
Page 1 of 2
| 510(k) NUMBER: | PENDING K041795 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8000 |
| CONTACT PERSON: | Cheryl BlakeVice President, Regulatory Affairs and Quality Systems |
| DATE OF PREPARATION: | June 30, 2004 |
| NAME OF DEVICE: | Optical Separator System |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
| TRADE NAME: | Optical Separator System |
| PREDICATE DEVICE: | Applied Medical Optical Separator (K032889)Applied Medical Insufflation Needle (K963359)Applied Medical, Rancho Santa Margarita, CA |
INTENDED USE: The Optical Separator 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 gain access through tissue planes and/or potential spaces for endoscopic instruments. The Optical Separator System may be used with or without visualization for primary and secondary insertions, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
DEVICE DESCRIPTION: The Optical Separator 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. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Dilating Tip Trocar dilates and separates tissue along its natural fiber lines in its path of entry.
The Optical Separator System will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.
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Page 2 of 2
The use of the Optical Separator System, which separates tissue along its natural fibers versus cutting of tissue by traditional bladed trocars, is expected to reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture. Upon removal of the trocar at the end of the procedure the separated tissue is expected to reapproximate, leaving a smaller, linear defect.
PERFORMANCE DATA SUMMARY: The performance and functional testing of the Optical Separator System included tests to verify the insertion force and tests to verify its reliability and visualization during use. The performance and functional testing demonstrated that the Optical Separator System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.
510(k) - ODE/FDA Optical Separator June 2004
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing a family or community. The figures are connected and appear to be in motion.
SEP 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Cheryl Blake Vice President, Regulatory Affairs and Quality Systems Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K041795
Trade/Device Name: Optical Separator System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 30, 2004 Received: July 2, 2004
Dear Ms. Blake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave dotenmined in arketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments proc to May 20, 1976, the occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Costiette Troty that to neview, subject to the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls providers a ractice, 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 If your device is classified (see acero) also Existing major regulations affecting your device can may be subject to satin address, legulations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oour of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toase be advised that I Dris assumes syour device complies with other requirements of the Act that I Dri has made a coulations administered by other Federal agencies. You must of any I cuchar statutes and regalations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC rut 0075, labeling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand by of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Cheryl Blake
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wif anow you to organization of substantial equivalence of your device to a legally premaired 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 If you desire specific as not as (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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
Applied Medical Resources is providing this separate cover page for the Optical Separator System "Indications for Use" as required.
510(k) Number: Not assigned K041795
Optical Separator System Device Name:
Indications for Use: The Optical Separator System is indicated for use in general, abdominal, muncations for Ose. The Opinimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
Signature: Title: Vice President RA and Quality Systems Date:6/30/2004
Prescription Use
(Per 21 CFR 801.109) X
OR Over-The -Counter Use - - -
(Optional Format 1-2-96)
510(k) - ODE/FDA Optical Separator June 2004
27
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K041795
§ 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.