(159 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
The reprocessed device has the same intended use as the original device and does not incorporate new technology, new materials, or design changes. The product code for the original device, GCJ, falls within 21 CFR §876.1500 for Endoscopes and Accessories. An Endoscope and Accessory device is defined within the code as 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. The accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. The Endoscopic Trocars and Cannulas specified in this submission are used in endoscopic procedures and are considered accessories to the endoscope. Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Surgical Endoscopic Trocars and Cannulas are available in a variety of configurations and materials as well as trocar and cannula sets. Trocar seals vary between single-port and multi-port seals. Endoscopy generally pertains to the use of a surgical instrument in conjunction with an endoscope inserted into the same body cavity. The endoscope permits visual inspection, with or without magnification, of the interior of the body cavity and permits observation of the surgical instrument during an operation for therapeutic or diagnostic purposes. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
Here's an analysis of the provided text regarding the acceptance criteria and study for the reprocessed trocars, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for the reprocessed trocars. Instead, it describes various tests performed to demonstrate that the reprocessed devices perform as originally intended and are substantially equivalent to predicate devices. The "reported device performance" is a general statement of successful completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Tests conducted to demonstrate performance |
| Validation of reprocessing | Tests conducted to demonstrate performance |
| Sterilization Validation | Tests conducted to demonstrate performance |
| Function test(s) | Tests conducted to demonstrate performance |
| Packaging Validation | Tests conducted to demonstrate performance |
| Overall Goal: Reprocessed Trocars perform as originally intended and are safe, effective, and substantially equivalent to predicate devices. | Conclusion: Reprocessed Trocars perform as originally intended; safe, effective, and substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation).
The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in the US, but this is not confirmed. The description suggests these were laboratory and bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of the device's performance characteristics. The tests described are objective, laboratory-based performance tests (e.g., sterilization efficacy, functional integrity, biocompatibility), which typically rely on established protocols and measurement standards rather than expert consensus on a "ground truth" in the way it might be used for diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the described performance tests are objective laboratory and bench tests, not assessments requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a reprocessed medical device, and the testing focuses on the physical, chemical, and functional characteristics of the reprocessed device compared to the original, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device in question is a physical medical instrument (trocar), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" is not applicable.
7. The Type of Ground Truth Used
For the performance tests described (Biocompatibility, Validation of Reprocessing, Sterilization Validation, Function Tests, Packaging Validation), the "ground truth" is provided by:
- Established standards and specifications: Each test would have pre-defined acceptance limits or criteria that the reprocessed device must meet. For example, sterilization validation would aim for a specific sterility assurance level (SAL), and function tests would verify that the mechanical components operate within factory specifications.
- Comparison to predicate device performance: The overall "ground truth" for substantial equivalence is that the reprocessed device performs identically to the new, original predicate device.
The document does not refer to "expert consensus," "pathology," or "outcomes data" as the ground truth for these specific performance tests.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This submission is for a reprocessed physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device submission, this information is not applicable.
{0}------------------------------------------------
Kob24497
Page 1 of 3
JAN 3 1 2007
PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| ------------ | ---------------------------------------------------------------------------------- |
Contact: Moira Barton-Varty Senior Director of Regulatory Affairs (480) 763-5350 (o) (480) 763-6089 (f) mbarton@ascenths.com
Date of preparation: July 24, 2006
Name of device: Trade/Proprietary Name: Reprocessed Trocars Classification Name: Iaparoscope, general & plastic surgery, reprocessed
| Predicate Device | 510(k) Title | Manufacturer |
|---|---|---|
| K032676 | ENDOPATH III Bladeless Trocars | Ethicon |
| K043253 | Vanguard Reprocessed Dilating Tip andBlunt Trocar (Ethicon) | Ascent Healthcare(Vanguard Medical) |
| K043594 | Vanguard Reprocessed Bladed Trocar,Non-Bladed Trocar (USSurgical/AutoSuture Series) | Ascent Healthcare(Vanguard Medical) |
List of Reprocessed Devices:
The following list represents specific Trocars models that will be reprocessed by Ascent Healthcare Solutions:
| Family | Cat. No. | Description | Sleeve Style | ID | Length |
|---|---|---|---|---|---|
| Ethicon-Endopath | B5ST | XCEL Bladeless Trocar | Stability | 5mm | 75mm |
| Ethicon-Endopath | B5SP | XCEL Bladeless Trocar | Smooth | 5mm | 75mm |
| XCELTrocar | CB5SP | XCEL Cannula | Smooth | 5mm | 75mm |
| XCELTrocar | CB5ST | XCEL Cannula | Stability | 5mm | 75mm |
| XCELTrocar | B5LT | XCEL Bladeless Trocar | Stability | 5mm | 100mm |
| XCELTrocar | B5LP | XCEL Bladeless Trocar | Smooth | 5mm | 100mm |
| XCELTrocar | CB5LP | XCEL Cannula | Smooth | 5mm | 100mm |
| XCELTrocar | CB5LT | XCEL Cannula | Stability | 5mm | 100mm |
Device description:
The reprocessed device has the same intended use as the original device and does not incorporate new technology, new materials, or design changes. The product code for the original device, GCJ, falls within 21 CFR §876.1500 for Endoscopes and Accessories.
An Endoscope and Accessory device is defined within the code as 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
Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)
{1}------------------------------------------------
| image to the user's eye. The accessories may assist in gaining accessor increase the versatility and augment the capabilities of the devices.1The Endoscopic Trocars and Cannulas specified in this submission areused in endoscopic procedures and are considered accessories to theendoscope. | |||
|---|---|---|---|
| Endoscopic Trocars and Cannulas are designed to establish a port ofentry for endoscopic instruments used during minimally invasivesurgery. Surgical Endoscopic Trocars and Cannulas are available in avariety of configurations and materials as well as trocar and cannulasets. Trocar seals vary between single-port and multi-port seals. | |||
| Endoscopy generally pertains to the use of a surgical instrument inconjunction with an endoscope inserted into the same body cavity. Theendoscope permits visual inspection, with or without magnification, ofthe interior of the body cavity and permits observation of the surgicalinstrument during an operation for therapeutic or diagnostic purposes. | |||
| Endoscopic surgery is conducted through a cannula that extendsacross the abdominal wall and provides channels where instruments,such as scopes, retractors and staplers, can be inserted to performsurgery. As part of this procedure, the abdominal cavity is inflated withan insufflation gas, such carbon dioxide, to maintain the abdomen in adistended state and provide increased instrument maneuveringcapability within the cavity. Valves are typically provided in the trocarsto form seals around the instruments to prevent leakage of theinsufflation gas. | |||
| Indicationsstatement: | Reprocessed Endoscopic Trocars are indicated for use to establish aport of entry for endoscopic instruments in patients requiringminimally invasive surgical procedures. | ||
| Technologicalcharacteristics: | The design, materials, and intended use of Reprocessed Trocars areidentical to the predicate devices. The mechanism of action ofReprocessed Trocars is identical to the predicate devices in that thesame standard mechanical design, materials, and sizes are utilized.There are no changes to the claims, intended use, clinicalapplications, patient population, performance specifications, ormethod of operation. In addition, Ascent Healthcare Solutionsreprocessing of Trocars includes removal of adherent visible soil anddecontamination. Each individual Trocars is tested for appropriatefunction of its components prior to packaging and labelingoperations. |
- Performance Bench and laboratory testing was conducted to demonstrate data: performance (safety and effectiveness) of Reprocessed Trocars. This included the following tests:
- Biocompatibility .
.
1 21 CFR 876.1500
Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)
{2}------------------------------------------------
Ko62497
Page 3. 83
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaging Validation .
Performance testing demonstrates that Reprocessed Trocars perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Trocars) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Moira Barton 10232 South 51st Street Phoenix, Arizona 85044
Re: K062497
Trade/Device Name: Reprocessed Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: November 29, 2006 Received: November 30, 2006
JAN 3 1 2007
Dear Ms. Barton:
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. 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
{4}------------------------------------------------
Page 2 - Ms. Moira Barton
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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely ypurs,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Kob2497
Indications for Use Statement 2.
510(k) Number (if known):
Device Name: Reprocessed Trocars
Indications for Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Dev CONFIDENTIAS 10(k) Number Assent Healthcare Solutions Traditional 510(k)
AND/OR
13
{6}------------------------------------------------
K062497
List of Reprocessed Devices:
| Family | Cat. No. | Description | Sleeve Style | ID | Length |
|---|---|---|---|---|---|
| Ethicon-EndopathXCELTrocar | B5ST | XCEL Bladeless Trocar | Stability | 5mm | 75mm |
| B5SP | XCEL Bladeless Trocar | Smooth | 5mm | 75mm | |
| CB5SP | XCEL Cannula | Smooth | 5mm | 75mm | |
| CB5ST | XCEL Cannula | Stability | 5mm | 75mm | |
| B5LT | XCEL Bladeless Trocar | Stability | 5mm | 100mm | |
| B5LP | XCEL Bladeless Trocar | Smooth | 5mm | 100mm | |
| CB5LP | XCEL Cannula | Smooth | 5mm | 100mm | |
| CB5LT | XCEL Cannula | Stability | 5mm | 100mm |
100 - 100 -
:
§ 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.