(159 days)
Not Found
No
The device description explicitly states that the reprocessed device "does not incorporate new technology, new materials, or design changes." The description focuses on the mechanical function of the trocars and cannulas for creating ports of entry and maintaining insufflation, with no mention of any computational or analytical capabilities that would suggest AI/ML. The performance studies are focused on reprocessing validation, sterilization, and basic functional tests, not on algorithmic performance.
No
The device, an endoscopic trocar, is used to establish access for endoscopic instruments during surgical procedures. While it facilitates surgical interventions that may be therapeutic, the trocar itself does not directly treat or cure a disease or condition; it is an accessory used for access in a surgical context, rather than a diagnostic or therapeutic tool itself.
No
The device, an endoscopic trocar, is used to establish an access port for endoscopic instruments during minimally invasive surgery. While an endoscope (which can be used for diagnostic purposes) might be inserted through this port, the trocar itself does not perform any diagnostic function. Its purpose is purely to facilitate access for other instruments, whether those instruments are used for diagnostic or therapeutic purposes.
No
The device description clearly describes a physical, reprocessed medical device (Endoscopic Trocars and Cannulas) used in surgical procedures, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures." This is a surgical tool used during a procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description clearly states it's an accessory to an endoscope used for surgical procedures within body cavities. It facilitates access and manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device falls under the category of surgical instruments used for accessing and working within the body during a procedure, which is distinct from the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NLM
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench and laboratory testing was conducted to demonstrate data: performance (safety and effectiveness) of Reprocessed Trocars. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaging Validation .
Performance testing demonstrates that Reprocessed Trocars perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Kob24497
Page 1 of 3
JAN 3 1 2007
PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, 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 and | |
| Blunt Trocar (Ethicon) | Ascent Healthcare | |
| (Vanguard Medical) | ||
| K043594 | Vanguard Reprocessed Bladed Trocar, | |
| Non-Bladed Trocar (US | ||
| Surgical/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 |
| XCEL | |||||
| Trocar | CB5SP | XCEL Cannula | Smooth | 5mm | 75mm |
| XCEL | |||||
| Trocar | CB5ST | XCEL Cannula | Stability | 5mm | 75mm |
| XCEL | |||||
| Trocar | B5LT | XCEL Bladeless Trocar | Stability | 5mm | 100mm |
| XCEL | |||||
| Trocar | B5LP | XCEL Bladeless Trocar | Smooth | 5mm | 100mm |
| XCEL | |||||
| Trocar | CB5LP | XCEL Cannula | Smooth | 5mm | 100mm |
| XCEL | |||||
| Trocar | 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 access
or increase the versatility and augment the capabilities of the devices.1
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. | | |
| Indications
statement: | Reprocessed Endoscopic Trocars are indicated for use to establish a
port of entry for endoscopic instruments in patients requiring
minimally invasive surgical procedures. | | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed Trocars are
identical to the predicate devices. The mechanism of action of
Reprocessed Trocars is identical to the predicate devices in that the
same standard mechanical design, materials, and sizes are utilized.
There are no changes to the claims, intended use, clinical
applications, patient population, performance specifications, or
method of operation. In addition, Ascent Healthcare Solutions
reprocessing of Trocars includes removal of adherent visible soil and
decontamination. Each individual Trocars is tested for appropriate
function of its components prior to packaging and labeling
operations. | | |
- 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- | |||||
| Endopath | |||||
| XCEL | |||||
| Trocar | 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 -
: