(452 days)
Not Found
No
The description focuses on a mechanical surgical tool for insufflation and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step, not a therapeutic intervention itself. It facilitates surgery, but doesn't treat a disease or condition.
No
Explanation: The device is intended for insufflation to establish pneumoperitoneum for surgical procedures, not for diagnosis.
No
The device description clearly indicates it is a physical, disposable surgical tool (needle) used for insufflation, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating a pneumoperitoneum for surgical procedures (laparoscopy). This is a surgical tool used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a surgical tool for insufflation during abdominal surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FHO, FHP, HIF
Device Description
The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons in operating room
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)
Mechanical bench testing of Luer lock operation, spring assembly resistance, disassembly test and indicator tests were conducted in comparison with the predicate. Ethicon Endopath Vercss Needle. In vivo testing including needle puncture tests and gas flow tests of insulTlation in a full-sized porcine model were conducted by a general surgeon with experience in laparoscopy. All performance tests show acceptable results and validate that the VECTEC Disposable Pneumoperitoneum Needle meets the intended use and product specifications.
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
1. GENERAL INFORMATION
1.1 Submitter and Owner of the 510(k)
Yves Arboy, President, VECTEC Z.I. Du Bioparc 03270 Hauterive FRANCE Establishment Registration No .: 3005459904
1.2 Official Correspondent
Diane Horwitz, Ph.D., RAC 2995 Steven Martin Dr. Fairfax, VA 22031 Telephone: 703.307.2921 Facsimile: 703.242.1117 Electronic mail: dinh@mandellhorwitzconsulting.com
1.3 Date of Preparation
August 2, 2013
NAME OF THE DEVICES 2.
2.1 Trade/Proprietary Names
VECTEC Disposable Pneumoperitoneum Needle
2.2 Classification Information
| Classification Name: | Endoscope and Accessories |
|---|---|
| Classification Regulation: | 21 CFR 876.1500 |
| Class: | II |
| Common Name: | Pneumoperitoneum Needle |
| Product Codes: | FHO, FHP, HIF |
| Panel: | Gastroenterology/Urology |
DESCRIPTION OF THE DEVICE 3.
The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
4. INTENDED USE / INDICATIONS FOR USE
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
1
5. PREDICATE DEVICES
| Predicate 1 | |
|---|---|
| Device Name: | Pneumo-Matic Insufflation Needle |
| 510(k) Number: | K970788 |
| Manufacturer: | Apple Medical Corporation |
Predicate 2 Endonath Veress Needle K910855 Ethicon Endosurgery Inc.
6. COMPARISON TO PREDICATES
This 510(k) submission claims substantial equivalence to the predicate devices by Apple Medical Corp., Pneumo-Matic Insufflation Needle, FHO/ 876.1500, K970788 and Ethicon Endosurgery Inc., Endopath Veress Needle, FDP/876.1500, K910875. The table below provides an overview of the comparison of the new device to the predicate devices. Overall, although there are minor differences between the design and materials between the devices, substantial equivalence between the new device and the predicate devices has been demonstrated.
| Characteristic | List of Similar Characteristics: VECTEC
Pneumoperitoneum Needle vs. Predicate Devices |
|------------------------------------------------|------------------------------------------------------------------------------------------|
| Users | Surgeons in operating room |
| Intended Use/Indication for Use | Access to peritoneal space during laparoscopic
surgery for insufflation with CO2 |
| Single-use disposable | Yes |
| Sterilized | Yes |
| Length | 120 mm and 150 mm |
| Diameter | 2.1 mm (14G) |
| Luer Lock connector | Yes |
| Spring-loaded | Yes |
| Indicator for when in peritoneal cavity | Yes (clear hub with red indicator) |
| On/Off gas flow switch | Present |
| Compliance with ISO 10993 for biocompatibility | Complies |
PERFORMANCE TESTING 7.
The VECTEC Disposable Pneumoperitoneum Needle is composed of biocompatible materials. Cytotoxicity, irritation and sensitization testing were conducted according to ISO 10993-1: 2009, ISO 10993-5:2009. ISO 10993-10: 2010. and ISO 10993-12: 2007. Sterilization validation was performed according to ISO 11135-1: 2007 and ethylene oxide residuals were monitored according to ISO 10993-7: 2008.
Mechanical bench testing of Luer lock operation, spring assembly resistance, disassembly test and indicator tests were conducted in comparison with the predicate. Ethicon Endopath Vercss Needle. In vivo testing including needle puncture tests and gas flow tests of insulTlation in a full-sized porcine model were conducted by a general surgeon with experience in laparoscopy. All performance tests show acceptable results and validate that the VECTEC Disposable Pneumoperitoneum Needle meets the intended use and product specifications.
છે. CONCLUSIONS
Based on the substantial equivalence analysis, which demonstrates similar intended use and technology between the new device and the predicates, the VECTEC Disposable Pocumoperitoneum Needles are concluded to be as safe and effective and substantially cquivalent to the predicate devices, supporting the clearance of the VECTEC Disposable Pneumoperitoncum Needles.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
VECTEC % Diane Mandell Horwitz, Ph.D., RAC Regulatory Consultant Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, VA 22031
Re: K121370
Trade/Device Name: VECTEC Disposable Pneumoperitoneum Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FHO, FHP, HIF Dated: July 24, 2013 Received: July 24, 2013
Dear Diane Mandell Horwitz,
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.
3
Page 2 - Diane Mandell Horwitz, Ph.D., RAC
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); 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/ReportalProblem/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 vours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K121370
Device Name: VECTEC Disposable Pneumoperitoneum Needle
Indications for Use:
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Prescription Use X 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K121370 510(k) Number _