(142 days)
The Dilating Tip Obturator 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 Dilating Tip Obturator 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 Dilating Tip Obturator 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 Dilating Tip Obturator will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.
The use of the Dilating Tip Obturator, 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dilating Tip Obturator:
Acceptance Criteria and Device Performance Study for the Dilating Tip Obturator (K012884)
The provided 510(k) summary for the Dilating Tip Obturator (K012884) describes a medical device, not an AI/ML algorithm or software. Therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable to this physical device submission.
The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device through performance and functional testing that shows it raises no new safety or effectiveness issues.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit based on 510(k) submission type) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device performs its intended functions (e.g., establishing a path of entry, gaining access through tissue planes) effectively. | The device is intended to establish a path of entry for endoscopic instruments or gain access through tissue planes/potential spaces. Performance testing included "tests to verify its reliability during use." |
| Safety Equivalence | Device does not introduce new safety concerns compared to the predicate. | The device is expected to "reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture" by separating tissue along natural fiber lines, as opposed to cutting. This implies an improvement in safety compared to bladed trocars. |
| Performance Metrics | Insertion Force: Should be within acceptable ranges or comparable to predicate. | Performance testing included "tests to verify the insertion force." The results demonstrated substantial equivalence. |
| Reliability during use | Device maintains integrity and functionality throughout the surgical procedure. | Performance testing included "tests to verify its reliability during use." The results demonstrated substantial equivalence. |
| Substantial Equivalence | All functional and safety aspects are substantially equivalent to the predicate device, or improved, without raising new questions of safety or effectiveness. | "The performance and functional testing demonstrated that the Dilating Tip Obturator is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device. The "test set" would refer to laboratory or bench testing on the device itself, not a dataset of images or patient information. The document does not specify the number of devices tested for insertion force or reliability. Data provenance (country of origin, retrospective/prospective) is also not applicable to bench testing of a physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth as typically understood for AI/ML (e.g., disease presence, image annotation) is not relevant here. The ground truth for device performance is typically established through engineering specifications and objective measurements against those specs or against predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on AI/ML ground truth, not for bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, on sets of clinical cases. This is not applicable to the evaluation of a physical surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" would be objective measurements of physical properties and performance characteristics, such as:
- Insertion Force: Measured in units of force (e.g., Newtons) under specified conditions.
- Reliability: Assessed by simulating use conditions and observing for failure, breakage, or loss of function.
- Material Properties: Conformance to material specifications, biocompatibility, sterility.
These are compared against predetermined standards or the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical device submission; there is no "training set" in the AI/ML sense. Any "training" for the device would refer to manufacturing process controls or operator training, not data used to train an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as #8.
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JAN 1 7 2002
510(k) SUMMAR Y
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8000 |
| CONTACT PERSON: | Anil BhalaniVice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | August 27, 2001 |
| NAME OF DEVICE: | Dilating Tip Obturator |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
| TRADE NAME: | Dilating Tip Obturator |
| PREDICATE DEVICE: | EndoPath Optiview Optical Surgical Obturator, Ethicon-Endo-Surgery, Inc. Cincinnati, OH. |
INTENDED USE: The Dilating Tip Obturator 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.
DEVICE DESCRIPTION: The Dilating Tip Obturator 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 Dilating Tip Obturator will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.
The use of the Dilating Tip Obturator, 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.
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PERFORMANCE DATA SUMMARY: The performance and functional testing of the Dilating Tip Obturator included tests to verify the insertion force and tests to verify its reliability during use. The performance and functional testing demonstrated that the Dilating Tip Obturator 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Anil Bhalani Vice-President of Regulatory Affairs and Clinical Programs Applied Medical 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K012884 Trade Name: Dilating Tip Obturator Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 26, 2001 Received: November 28, 2001
Dear Mr. Bhalani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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.
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Page 2 - Mr. Anil Bhalani
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally prematics notification " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor goneral 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,
Mark n Milkman
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 Dilating Tip Obturator "Indications for Use" as required.
510(k) Number: Not assigned
Dilating Tip Obturator Device Name:
Indications for Use: The Dilating Tip Obturator 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: Vice President of RA/Clinical Programs Date: 8-27-01
(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 | |
|---|---|---|---|---|
| Mark N. Melker (Division Sign-Off) | (Optional Format 1-2-96) | |||
| Division of General, Restorativeand Neurological Devices | ||||
| 510(k) Number | K012884 |
42
§ 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.