(15 days)
The Optical Separator 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 may be used with or without visualization for primary and secondary insertions.
The Optical Separator 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.
The Optical Separator 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 Optical Separator dilates and separates tissue along its natural fiber lines in its path of entry.
The Optical Separator will be available in sizes of 5mm, 8mm, 11mm and 12mm diameter and in lengths ranging from 55mm to 150mm.
The use of the Optical Separator, 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.
This document describes the Optical Separator, a sterile, single-use device designed to establish a path of entry for endoscopic instruments in various minimally invasive surgical procedures. The device aims to reduce trauma by dilating and separating tissue along natural fiber lines instead of cutting.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Insertion Force | N/A (Not explicitly stated, but implies meeting a threshold appropriate for intended use) | "tests to verify the insertion force" were performed. |
| Reliability | N/A (Not explicitly stated, but implies consistent function and structural integrity during use) | "tests to verify its reliability" were performed. |
| Visualization | N/A (Not explicitly stated, but implies adequate visualization during use with an endoscope) | "tests to verify... visualization during use" were performed. |
| Safety and Effectiveness | Substantial equivalence to predicate devices, and no new safety and effectiveness issues. | "The performance and functional testing demonstrated that the Optical Separator is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." |
2. Sample Size and Data Provenance for Test Set
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is general "performance and functional testing" rather than a clinical study with a defined test set of patient data.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth as this was not a study involving diagnostic interpretation or subjective assessment. The testing described focuses on mechanical and functional performance characteristics of the device.
4. Adjudication Method for Test Set
No adjudication method is mentioned as there was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned. This device is a surgical instrument, not a diagnostic imaging aid that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was performed or mentioned. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for assessing the device's performance was based on:
- Engineering specifications and standards: Implicit in the "tests to verify insertion force," "reliability," and "visualization."
- Comparison to predicate devices: The primary ground truth for regulatory approval was demonstrating "substantial equivalence" to existing, legally marketed predicate devices (EndoPath Optiview Optical Surgical Obturator and Applied Medical Dilating Tip Obturator). This implies that the performance of the predicate devices served as a benchmark for safety and effectiveness.
8. Sample Size for Training Set
The concept of a "training set" is not applicable here as this is a physical medical device undergoing performance and functional testing, not a machine learning algorithm.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set mentioned for this type of device.
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K032889 1/2 OCT - 2 2003 510(k) SUMMARY PENDING 510(k) NUMBER: Applied Medical Resources Corporation SUBMITTED BY: 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000 CONTACT PERSON: Cheryl Blake Applied Medical 22872 Avenida Empresa Ranch Santa Margarita, CA 92688 Telephone 949-713-8327 fax number(s) 949-713-8502 and 949-713-8200 e-mail cblake(@appliedmed.com August 27, 2003 DATE OF PREPARATION: NAME OF DEVICE: Optical Separator CLASSIFICATION NAME: Laparoscope, General & Plastic Surgery (21CFR 876.1500) TRADE NAME: Optical Separator PREDICATE DEVICE: EndoPath Optiview Optical Surgical Obturator, Ethicon-Endo-Surgery, Inc. Cincinnati, OH. (K990028) Applied Medical Dilating Tip Obturator Applied Medical, Rancho Santa Margarita, CA (K012884)
INTENDED USE: The Optical Separator 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 may be used with or without visualization for primary and secondary insertions.
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DEVICE DESCRIPTION: The Optical Separator 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 Optical Separator dilates and separates tissue along its natural fiber lines in its path of entry.
The Optical Separator will be available in sizes of 5mm, 8mm, 11mm and 12mm diameter and in lengths ranging from 55mm to 150mm.
The use of the Optical Separator, 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 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 is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.
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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 features a stylized image of an eagle with its wings spread, with three human figures in profile below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the image in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Applied Medical Resources c/o Ms. Ellen Fickewirth Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4269
Re: K032889 Trade/Device Name: Optical Separator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 15, 2003 Received: September 17, 2003
Dear Ms. Fickewirth:
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, 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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Ellen Fickewirth
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 (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 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/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 "Indications for Use" as required.
Not assigned 510(k) Number:
Device Name: Optical Separator
Indications for Use: The Optical Separator 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.
Signature:
Title: Director of RA/Clinical Programs Date: 8-27-03
uriam C Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032889
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The -Counter Use
(Optional Format 1-2-96)
510(k) - ODE/FDA Optical Separator August 2003
§ 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.