(298 days)
Not Found
No
The document describes a reprocessed surgical instrument (trocar) and its intended use and testing, with no mention of AI or ML technology.
No
Therapeutic devices are used to treat or cure a disease or condition. This device is used to establish a port of entry for surgical instruments, which is an ancillary function to a surgical procedure, not a treatment in itself.
No
Explanation: This device is a surgical instrument used to establish a port of entry for other endoscopic instruments during minimally invasive surgery. Its function is to facilitate access for surgical procedures, not to diagnose conditions.
No
The device description clearly states it is a physical device (trocars and cannulas) used to establish a port of entry, and the performance studies involve bench and laboratory testing of physical properties and processes like reprocessing and sterilization.
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 describes a surgical tool used directly on a patient during a procedure, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of the trocars and cannulas for surgical access.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reprocessed Endoscopic Trocars and Cannulas are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic, therapeutic and operative instruments into the abdominal and thoracic cavities, and for percutaneous access to hollow body organs. Reprocessed Endoscopic Trocars and Cannulas are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Product codes
NLM
Device Description
Reprocessed Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic cavities, hollow body organs
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Trocars and Cannulas. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation ●
- Function test(s) .
- . Packaging Validation
Performance testing demonstrates that Reprocessed Endoscopic Trocars and Cannulas perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041795, K032889, K012884, K012968
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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P910+3
PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | OCT 15 2007 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Contact: | Katie Bray
RA Specialist/Biomedical Engineer
(480) 763-5300 (o)
(480) 763-6089 (f)
kbray@ascenths.com | |
| Date of preparation: | December 13, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Endoscopic Trocars and
Cannulas
Classification Name: Laparoscope, general & plastic surgery,
reprocessed | |
| Predicate Device | 510(k) Title | Manufacturer |
| K041795 | Modification to Optical Separator | Applied Medical |
| K032889 | Optical Separator | Applied Medical |
| K012884 | Dilating Tip Obturator | Applied Medical |
| K012968 | Trocar Seal | Applied Medical |
| Device description: | Reprocessed Endoscopic Trocars and Cannulas are designed
to establish a port of entry for endoscopic instruments used
during minimally invasive surgery. 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. | |
Bladed Trocars
| Manufacturer | Description | Model |
|---|---|---|
| Applied Medical | 11mm x 100mm Shielded Obturator with Universal Seal, non- | |
| threaded | C0638 | |
| Applied Medical | 12mm x 100mm Shielded Obturator with Universal Seal, non- | |
| threaded | C0639 | |
| Applied Medical | 11mm x 100mm Shielded Obturator with Universal Seal, threaded | C0658 |
| Applied Medical | 12mm x 100mm Shielded Obturator with Universal Seal, threaded | C0659 |
1
| く
| 0 | 1637 | -88 | |
|---|---|---|---|
| Non-Bladed Trocars | ||
|---|---|---|
| Manufacturer | Description | Model |
| Applied Medical | 12mm blunt tip trocar | C0718 |
| Applied Medical | 11mm blunt tip trocar | C0717 |
| Applied Medical | 12mm x 100mm Optical Separator system, handled, non-threaded | C0124 |
| Applied Medical | 12mm x 100mm Optical Separator system, handled, threaded | C0128 |
| Applied Medical | 12mm x 100mm Optical Separator system, non-handled, non-threaded | C0126 |
| Applied Medical | 12mm x 100mm Optical Separator system, non-handled, threaded | C0130 |
| Applied Medical | 11mm x 100mm Optical Separator system, handled, non-threaded | C0114 |
| Applied Medical | 11mm x 100mm Optical Separator system, handled, threaded | C0150 |
| Applied Medical | 11mm x 100mm Optical Separator system, non-handled, non-threaded | C0116 |
| Applied Medical | 11mm x 100mm Optical Separator system, non-handled, threaded | C0152 |
| Applied Medical | 8mm x 100mm Optical Separator system, non-threaded | C0675 |
| Applied Medical | 8mm x 100mm Optical Separator system, threaded | C0676 |
| Applied Medical | 15mm x 100mm Separator system with Universal seal, non-threaded | C0604 |
| Applied Medical | 15mm x 100mm Separator system with Universal seal, threaded | C0605 |
| Applied Medical | 12mm x 100mm Separator system with Universal seal, non-threaded | C0682 |
| Applied Medical | 12mm x 100mm Separator system with Universal seal, threaded | C0680 |
| Applied Medical | 11mm x 100mm Separator system with Universal seal, non-threaded | C0667 |
| Applied Medical | 11mm x 100mm Separator system with Universal seal, threaded | C0665 |
| Applied Medical | 12mm x 100mm Optical Separator, obturator, handled | C0120 |
| Applied Medical | 12mm x 100mm Optical Separator, obturator, non-handled | C0122 |
| Applied Medical | 12mm x 100mm Separator obturator | C0930 |
| Applied Medical | 11mm x 100mm Separator obturator | C0915 |
| Applied Medical | 5mm x 100mm Separator obturator | C0901 |
| Applied Medical | 5mm x 55mm Separator obturator | C0900 |
Stability Cones and Seals
| Manufacturer | Description | Model |
|---|---|---|
| Applied Medical | 10/11mm Conductive Stability Cone | C0704 |
| Applied Medical | 10/12mm Conductive Stability Cone | C0705 |
| Applied Medical | 12mm disposable non-conductive stability cone | C0707 |
| Applied Medical | 11mm disposable non-conductive stability cone | C0706 |
| Applied Medical | 12mm x 100mm cannula and Universal seal, non-threaded | C0632 |
| Applied Medical | 12mm x 100mm cannula and Universal seal, threaded | C0652 |
| Applied Medical | 11mm x 100mm cannula and Universal seal, non-threaded | C0631 |
| Applied Medical | 11mm x 100mm cannula and Universal seal, threaded | C0651 |
| Applied Medical | Universal® Seals | C0600 |
Reprocessed Endoscopic Trocars and Cannulas are intended Intended use: for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic, therapeutic and operative instruments into the abdominal and thoracic cavities, and for percutaneous access to hollow body organs. Reprocessed Endoscopic Trocars and Cannulas are indicated Indications for use to establish a port of entry for endoscopic instruments in statement: patients requiring minimally invasive surgical procedures. Ascent Healthcare Solutions 10 Reprocessed Endoscopic Trocars and Cannulas
Traditional 510(k)
2
K063788 Pg 3 of 3
The design, materials, and intended use of Reprocessed Technological Endoscopic Trocars and Cannulas are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed Endoscopic Trocars and Cannulas 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's reprocessing of Endoscopic Trocars and Cannulas includes removal of adherent visible soil and decontamination. Each individual Endoscopic Trocars and Cannulas is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Trocars and Cannulas. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation ●
- Function test(s) .
- . Packaging Validation
Performance testing demonstrates that Reprocessed Endoscopic Trocars and Cannulas perform as originally intended.
Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Endoscopic Trocars and Cannulas) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed Endoscopic Trocars and Cannulas Traditional 510(k)
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
% Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044
Ascent Healthcare Solutions
Re: K063788
Trade/Device Name: Reprocessed Endoscopic Trocars and Cannulas Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: October 3, 2007 Received: October 5 2007
Dear Ms. Bray:
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.
4
Page 2 - Ms. Katie Bray
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 (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 yours.
Fa Nh Dm
Mark N. Melkerson
Ar Qr
10 lixdr
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
List of Devices:
| Manufacturer | Description | Model |
|---|---|---|
| Applied Medical | 12mm blunt tip trocar | C0718 |
| Applied Medical | 11mm blunt tip trocar | C0717 |
| Applied Medical | 12mm x 100mm Optical Separator system, handled, non-threaded | C0124 |
| Applied Medical | 12mm x 100mm Optical Separator system, handled, threaded | C0128 |
| Applied Medical | 12mm x 100mm Optical Separator system, non-handled, non-threaded | C0126 |
| Applied Medical | 12mm x 100mm Optical Separator system, non-handled, threaded | C0130 |
| Applied Medical | 11mm x 100mm Optical Separator system, handled, non-threaded | C0114 |
| Applied Medical | 11mm x 100mm Optical Separator system, handled, threaded | C0150 |
| Applied Medical | 11mm x 100mm Optical Separator system, non-handled, non-threaded | C0116 |
| Applied Medical | 11mm x 100mm Optical Separator system, non-handled, threaded | C0152 |
| Applied Medical | 8mm x 100mm Optical Separator system, non-threaded | C0675 |
| Applied Medical | 8mm x 100mm Optical Separator system, threaded | C0676 |
| Applied Medical | 15mm x 100mm Separator system with Universal seal, non-threaded | C0604 |
| Applied Medical | 15mm x 100mm Separator system with Universal seal, threaded | C0605 |
| Applied Medical | 12mm x 100mm Separator system with Universal seal, non-threaded | C0682 |
| Applied Medical | 12mm x 100mm Separator system with Universal seal, threaded | C0680 |
| Applied Medical | 11mm x 100mm Separator system with Universal seal, non-threaded | C0667 |
| Applied Medical | 11mm x 100mm Separator system with Universal seal, threaded | C0665 |
| Applied Medical | 12mm x 100mm Optical Separator, obturator, handled | C0120 |
| Applied Medical | 12mm x 100mm Optical Separator, obturator, non-handled | C0122 |
| Applied Medical | 12mm x 100mm Separator obturator | C0930 |
| Applied Medical | 11mm x 100mm Separator obturator | C0915 |
| Applied Medical | 5mm x 100mm Separator obturator | C0901 |
| Applied Medical | 5mm x 55mm Separator obturator | C0900 |
| Manufacturer | Description | Model |
|---|---|---|
| Applied Medical | 11mm x 100mm Shielded Obturator with Universal Seal, non-threaded | C0638 |
| Applied Medical | 12mm x 100mm Shielded Obturator with Universal Seal, non-threaded | C0639 |
| Applied Medical | 11mm x 100mm Shielded Obturator with Universal Seal, threaded | C0658 |
| Applied Medical | 12mm x 100mm Shielded Obturator with Universal Seal, threaded | C0659 |
| Manufacturer | Description | Model |
|---|---|---|
| Applied Medical | 10/11mm Conductive Stability Cone | C0704 |
| Applied Medical | 10/12mm Conductive Stability Cone | C0705 |
| Applied Medical | 12mm disposable non-conductive stability cone | C0707 |
| Applied Medical | 11mm disposable non-conductive stability cone | C0706 |
| Applied Medical | 12mm x 100mm cannula and Universal seal, non-threaded | C0632 |
| Applied Medical | 12mm x 100mm cannula and Universal seal, threaded | C0652 |
| Applied Medical | 11mm x 100mm cannula and Universal seal, non-threaded | C0631 |
| Applied Medical | 11mm x 100mm cannula and Universal seal, threaded | C0651 |
| Applied Medical | Universal® Seals | C0600 |
6
pg 1 of 1
Indications for Use Statement 1.
510(k) Number (if known):
Device Name: Reprocessed Endoscopic Trocars and Cannulas
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.
AND/OR 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 of General, Restorative,
and Neurological Devices
1106374
510(k) Number