(66 days)
Not Found
No
The summary explicitly states that the reprocessed device does not incorporate new technology or design changes, and there are no mentions of AI, ML, or related concepts.
No.
The device is used to create a port of entry for surgical instruments during minimally invasive procedures, not to treat a disease or condition itself.
No
The device description and intended use clearly state that the trocars are used to establish a port of entry for surgical instruments during minimally invasive procedures. There is no mention of the device being used to diagnose conditions or collect diagnostic information.
No
The device description clearly details physical components like cannulas, obturators, threaded sleeves, sealing systems, and luer stopcock ports, indicating it is a hardware device.
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 on the patient's body, not a device used to examine specimens from the body to diagnose or monitor a condition.
- Device Description: The description details a surgical instrument (trocar and cannula) used for creating access during surgery. It mentions features like a sealing system, luer stopcock, and optical obturator, all related to surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a surgical instrument, not 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)
NLM
Device Description
Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.
The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.
Trocar Obturator is available in bladeless configuration sized 5 mm. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury.
The Reprocessed Trocar (model B5LT) includes the Cannula and Obturator components and will be used as the master product for validation. Model CB5LT consist solely of the Cannula component. A Cannula is designed to provide an access port for endoscopic instruments during minimally invasive surgical procedures. The design features of the cannnula include:
- Cannula sleeve is available in stability configuration with a 5mm inner diameter and 100mm length;
- Reprocessed stopcock valve minimizes inadvertent opening/closing of the valve during surgery, reducing overall procedure time;
- Instrument valve maintains pneumoperitoneum during insertion and withdrawal of instruments.
The Obturator is designed for incision and separation of the abdominal wall to provide the access port for the cannula sleeve. The design features of the obturator include:
- Distal tip is bladeless. Non-bladed obturators require greater penetration force than bladed obturators, but pose less risk for visceral/vascular damage.
- Tapered tip of the trocar is clear, providing visibility of tissue layers when used with an endoscope during insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Not Found
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
K1000g0
Page 1 of ②
SECTION 10: EXECUTIVE SUMMARY
SUBMITTER INFORMATION:
Applicant
Contact Person
MAR 1 9 2010
Ascent Healthcare Solutions 10232 South 51st Street Phoenix, Arizona 85044
Moira Barton-Varty Senior Director Requlatory Affairs 480.763.5300 (o) 480.763.5350 (f) mbarton@ascenths.com
Representative/Consultant
N/A
Establishment Registration Number 1056128
Address of Manufacturing Site
Ascent Healthcare Solutions 5307 Great Oak Drive Lakeland, FL 33815
DESCRIPTION OF THE REPROCESSED DEVICE :
Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.
The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.
Trocar Obturator is available in bladeless configuration sized 5 mm.. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury
The reprocessed device has the same intended use as the original device and does not incorporate new technology or design changes. The product code for the original device. GCJ, falls within 21 CFR §876.1500 for Endoscopes and Accessories.
Device Trade or Proprietary Reprocessed Trocars Name:
Laparoscope, General & Plastic Surgery, Reprocessed Device Common, Usual or Classification Name:
CONFIDENTIAL
1
K1 000 80
11
Page 2 of 2
Classification Information:
Class: Panel: Product Code: Citation:
Gastroenterology/Urology NEM 21 CFR §Section: 876.1500
INDICATIONS FOR USE
Reprocessed Endoscopic Trocars are indicated for use to establish a port entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
PRINCIPLES OF OPERATION
Minimally invasive operative techniques involve a number of stages that vary according to surgeon preference and training. The sites, sizes, and the number and type of trocars placed also vary with the procedure and surgeon preference. The first step is to establish pneumoperitoneum. Typically, a Veress needle is inserted through a small paraumbilical incision to initiate the pneumoperitoneum. To prevent visceral injury, the patient is positioned to displace the small bowel from the pelvis. The Veress needle is inserted pointing inferiorly and insufflation with carbon dioxide is begun until an intraperitoneal pressure of 12 to 18 mm Hg is attained. The needle is then removed and replaced with a trocar through which a video laparoscope is inserted. The peritoneal cavity is inspected to identify any injury caused by the initial insertions. Then the remaining trocars are placed under direct laparoscopic observation, minimizing the possibility of visceral injury. Different surgical instruments are then inserted through these access ports to perform the surgical procedure.
TABLE OF COMPARISON
The design of the reprocessed device is the same as the predicate device. The same standard mechanical design, sizes and materials are utilized. There are no changes to the claims, clinical applications, patient population, or performance specifications.
The information in this traditional 510(k) submission is consistent with the information submitted in K062497 for Reprocessed Trocars. K062497 included information for trocars that are limited to one (1) reprocessing cycle. This 510(k) includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044
Re: K100080
MAR 1 9 2010
Trade/Device Name: Reprocessed Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: January 11, 2010 Received: January 12, 2010
Dear Ms. Barton-Varty:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Moira Barton-Varty
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
cerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
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_ × (Part 21 CFR 801 Subpart D)
AND/OR
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)
Neil RP Qulm form
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K1000870
5
SECTION 11: DEVICE DESCRIPTION
LIST OF REPROCESSED DEVICES
The following table describes the specific Trocar models that will be reprocessed by Ascent Healthcare Solutions:
| Family | Cat.
No. | Description | Sleeve
Style | ID | Length |
|-------------------------------------------------|-------------|-------------------------|-----------------|-----|--------|
| Ethicon
ENDOPATH® XCEL™
Bladeless Trocars | B5LT | XCEL
BladelessTrocar | Stability | 5mm | 100mm |
| | CB5LT | XCEL Cannula | Stability | 5mm | 100mm |
Table 11.1 List of Reprocessed Trocars
PHYSICAL DESCRIPTION/SPECIFICATION
The Reprocessed Trocar (model B5LT) includes the Cannula and Obturator components and will be used as the master product for validation. Model CB5LT consist solely of the Cannula component. A Cannula is designed to provide an access port for endoscopic instruments during minimally invasive surgical procedures. The design features of the cannnula include:
- . Cannula sleeve is available in stability configuration with a 5mm inner diameter and 100mm length;
- Reprocessed stopcock valve minimizes inadvertent opening/closing of the valve . during surgery, reducing overall procedure time;
- Instrument valve maintains pneumoperitoneum during insertion and withdrawal of . instruments.
The Obturator is designed for incision and separation of the abdominal wall to provide the access port for the cannula sleeve. The design features of the obturator include:
- . Distal tip is bladeless. Non-bladed obturators require greater penetration force than bladed obturators, but pose less risk for visceral/vascular damage.
- . Tapered tip of the trocar is clear, providing visibility of tissue layers when used with an endoscope during insertion.
A.t. Reeder for nxt
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100080
CONFIDENTIAL