(90 days)
The Applied Access Seal is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products for use as a port of entry for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
A standard trocar assembly consists of an obturator, a seal and a cannula system. The Applied Access Seal is designed for use with Applied Medical's Cannulas and Obturators. An Applied Medical Trocar will consist of the Applied Access Seal, a cannula and an obturator.
The Applied Access Seal when used in laparoscopic surgery is designed to maintain pneumoperitoneum or positive pressure at its distal end to prevent loss of surgical gas. The device is designed to seal around surgical instruments, which are typically inserted through the device during surgery, to prevent loss of pneumoperitoneum during use and exchange of such instruments. The Applied Access seal is available with a stop-cock through which carbon dioxide or other gas may be dispensed into the surgical site during laparoscopic surgery.
The Applied Access Seal is made from materials used in currently marketed medical devices and has passed biocompatibility testing required per ISO 10993-1.
The provided text describes a medical device, the Applied Access Seal, and its 510(k) submission. However, it does not include detailed acceptance criteria or a study that specifically "proves" the device meets them in the way modern AI/software device submissions would.
This 510(k) submission is for a physical device (Trocar Seal), not an AI/software device. The regulatory pathway for this type of device in 2001 focused on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance metrics against pre-defined acceptance criteria in the manner requested for an AI/software study.
Therefore, many of the requested points are not applicable or cannot be extracted from the provided text. I will address the points based on the information available and explicitly state when information is missing or not applicable to this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of Seal (to maintain pneumoperitoneum) | Demonstrated substantial equivalence to predicate device. |
| Leakage through the Seal (to prevent loss of surgical gas) | Demonstrated substantial equivalence to predicate device. |
| Biocompatibility (materials used in currently marketed devices) | Passed biocompatibility testing required per ISO 10993-1. |
Explanation of Implied Criteria:
The document states, "The performance and functional testing of the Applied Access Seal included tests to verify integrity of seal and leakage through the seal." These are implied performance criteria for a trocar seal. The primary method of "meeting" these criteria in a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing seems to have been conducted on the physical device itself, not on a dataset of patient images or clinical data as would be the case for an AI/software device.
- Data Provenance: Not applicable in the context of an AI/software device. The testing was functional on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical medical instrument. The "ground truth" would be objective measurements of seal integrity and leakage, not expert interpretation of data.
4. Adjudication method for the test set:
- Not applicable. This is not an AI/software study requiring adjudication of expert interpretations.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The device performs its function independently.
7. The type of ground truth used:
- For the performance tests (seal integrity, leakage), the "ground truth" would be objective physical measurements using scientific instruments and test methods to quantify parameters like pressure maintenance, flow rates, or visual inspection of seal integrity under stress.
- For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards and successful completion of the required tests.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model was used.
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| DEC 0 3 2001 | 510(k) SUMMARY |
|---|---|
| 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 31, 2001 |
| NAME OF DEVICE: | Trocar Seal |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
| TRADE NAME: | Applied Access Seal |
| PREDICATE DEVICE: | Premium Disposable Seal, Applied Medical Resources(K932995) |
INTENDED USE: The Applied Access Seal is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products for use as a port of entry for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
DEVICE DESCRIPTION: A standard trocar assembly consists of an obturator, a seal and a cannula system. The Applied Access Seal is designed for use with Applied Medical's Cannulas and Obturators. An Applied Medical Trocar will consist of the Applied Access Seal, a cannula and an obturator.
The Applied Access Seal when used in laparoscopic surgery is designed to maintain pneumoperitoneum or positive pressure at its distal end to prevent loss of surgical gas. The device is designed to seal around surgical instruments, which are typically inserted through the device during surgery, to prevent loss of pneumoperitoneum during use and exchange of such instruments. The Applied Access seal is available with a stop-cock through which carbon dioxide or other gas may be dispensed into the surgical site during laparoscopic surgery.
The Applied Access Seal is made from materials used in currently marketed medical devices and has passed biocompatibility testing required per ISO 10993-1.
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PERFORMANCE DATA SUMMARY: The performance and functional testing of the Applied Access Seal included tests to verify integrity of seal and leakage through the seal. The performance and functional testing demonstrated that the Applied Access Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K012968
Trade/Device Name: Applied Access Seal Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 31, 2001 Received: September 4, 2001
Dear Mr. Bhalani:
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 (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) I mis letter will anow you to cogen finding of substantial equivalence of your device to a legally promatics notification. The Pro Linessification 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Fart 007.10 for questions on the promotion and advertising of Comphance ut (301) 594-1697 ffice 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 Outer general miormational 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,
Susan Walker
fa
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 Applied Access Seal "Indications for Use" as required.
Not assigned K012968 510(k) Number:
Applied Access Seal Device Name:
Indications for Use: The Applied Access Seal is a sterile single use device, indicated for use in conjunction with Applied's currently marketed Trocar products where a port of entry is desired for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
(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)
Susan Wall
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number: K012968
§ 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.