(30 days)
No
The device description details a purely mechanical and electrical system (spring-loaded stylet, LED indicator, luer lock, stop cock) with no mention of algorithms, data processing, or learning capabilities. The performance studies focus on mechanical, electrical, and biocompatibility aspects, not algorithmic performance.
No.
The device is used to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery rather than a treatment itself. It facilitates a medical procedure but does not directly treat a disease or condition.
No
Explanation: The LaparoLight™ Veress Needle is intended for insufflation and establishing pneumoperitoneum. While it has an LED indicator for blunt tip position, this is a feedback mechanism for proper device operation, not for diagnosing a medical condition.
No
The device description clearly details a physical medical device (Veress needle) with integrated hardware components (LED indicator, spring-loaded stylet, luer lock, stop cock). The performance studies also focus on the physical and electrical characteristics of the hardware.
Based on the provided information, the LaparoLight™ Veress Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for percutaneous insertion into the peritoneal cavity for insufflation with carbon dioxide to establish pneumoperitoneum. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a needle designed for physical insertion and gas delivery into a body cavity. It includes mechanical and electrical components for this purpose.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples and provide diagnostic information. The LaparoLight™ Veress Needle is an in vivo (within the living body) surgical instrument.
N/A
Intended Use / Indications for Use
The LaparoLight™ Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Product codes
HIF, FHO
Device Description
The LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.
LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.
In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital
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)
Biocompatibility Testing: The biocompatibility evaluation for the LaparoLight™ Veress Needle was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests: In Vitro Cytotoxicity, Maximization Sensitization, Intracuteneous Reactivity, Systemic Toxicity Testing, Rabbit Pyrogen Testing. The test results demonstrate that the subject device is biocompatible.
Electrical Safety and Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing were conducted on the LaparoLight™ Veress Needle. The system complies with AAMI/ANSI ES 60601-1:2005/(R)2012 And A 1:2012 standard for electrical safety and IEC 60601-1-2 Edition 4.0 2014-02 standard for EMC.
Performance Testing - Bench: The following bench tests were performed for this submission, and the subject device passed all tests.
- LaparoLight™ Veress Needle Design Validation: Validation test included puncturing of simulated tissue, operation of blunt tip position indicator, saline and gas delivery.
- LaparoLight™ Veress Needle Force Equivalency: Force testing was conducted to confirm that the force of the spring loaded blunt stylet and puncture force are similar to the predicate device.
- LaparoLight™ Veress Needle Tip Pull Test: Testing to confirm equivalence to predicate device performance with regard to strength of bond between components.
- LaparoLight™ Veress Needle Switch Operation Test: Testing to confirm equivalence to predicate device performance by testing control of gas flow with stop cock/flow controller assembly.
- LaparoLight™ Veress Needle Spring Obturator Operation Test: Testing to confirm equivalence to predicate device performance – testing covered "click" of the needle and blunt tip extension once the needle enters open internal volume.
- LaparoLight™ Veress Needle Puncture Force Test: Testing to confirm equivalence to predicate device performance – testing covered puncture force required to puncture tissue simulator.
Conclusion: The performance testing demonstrates that the LaparoLight™ Veress Needle is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2017
Buffalo Filter, LLC % Mark A. Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313
Re: K171139
Trade/Device Name: LaproLight™ Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Unclassified Product Code: HIF Dated: April 17, 2017 Received: April 18, 2017
Dear Mark A. Job:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Benjamin/R. Fisher -S
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
2
Indications for Use
510(k) Number (if known)
Device Name LaparoLight™ Veress Needle
Indications for Use (Describe)
The LaparoLight™ Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K171139 page 1 of 4
Image /page/3/Picture/1 description: The image shows the logo for Buffalo Filter Filtration Group. The logo features a spiral of green and blue dots on the left side. To the right of the spiral is the company name, "BUFFALO FILTER," in blue, with "Filtration Group" in gray underneath.
510(k) Summary For LAPAROLIGHT™ VERESS NEEDLE
Submitter:
Buffalo Filter, LLC 5900 Genesee Street Lancaster, NY 14086 Phone: (716) 835-7000 Fax No: (716) 835-3414 FDA Registration number: 1319744
| Contact: | Kyrylo Shvetsov |
|---|---|
| Program Manager, NPD | |
| Senior Engineer | |
| Telephone: (716) 835-7000 | |
| Fax No: (716) 835-3414 |
Prepared Date: March 20, 2017
1. Device Name
| Trade Name: | LaparoLight™ Veress Needle, models LLVN12001
and LLVN15001 |
|----------------------|--------------------------------------------------------------------------|
| Common/Usual Name: | Veress Needle |
| Classification Name: | Insufflator, Laparoscopic (21 CFR 884.1730,
Product Code: HIF and FHO |
2. Predicate Device
Buffalo Filter claims substantial equivalence to:
Unimax Medical Systems Inc, Unimax Veress Needle (K111441)
This predicate device has not been subjected to a design-related recall.
4
3. Description of Device
The LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.
LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.
In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.
4. Intended Use
The LaparoLight M Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
ട്. Description of Substantial Equivalence
The subject and predicate device have the same intended use.
At a high level, the subject and predicate devices are based on following same technological elements:
- Spring loaded blunt stylet - used to protect internal organs from sharp of cannula.
- Blunt tip exposure indicator an indicator that shows to the user if blunt tip is ● extended or retracted
- . Luer Lock - connection point for syringe to perform saline test and insufflation tubing for CO2 gas delivery
- Stop Cock - to control gas passage through the needle
5
The following technological differences exist between the subject and predicate device:
- Type of Blunt tip exposure indicator LaparoLight™ Veress Needle contains ● an LED instead of a red marker painted on the needle hub that shows if blunt tip is extended
- Slip Sheet for product activation prior to use .
The differences in technology do not raise different questions of safety and effectiveness.
Performance Data 6.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the LaparoLight™ Veress Needle was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:
- · In Vitro Cytotoxicity
- · Maximization Sensitization
- Intracuteneous Reactivity
- · Systemic Toxicity Testing
- · Rabbit Pyrogen Testing
The LaparoLight™ Veress Needle is considered a device that contacts the Tissue / bone / dentin for a limited contact duration (less than 24hrs). The test results demonstrate that the subject device is biocompatible.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the LaparoLight™ Veress Needle. The system complies with AAMI/ANSI ES 60601-1:2005/(R)2012 And A 1:2012 standard for electrical safety and IEC 60601-1-2 Edition 4.0 2014-02 standard for EMC.
6
Performance Testing - Bench
The following bench tests were performed for this submission, and the subject device passed all tests.
-
LaparoLight™ Veress Needle Design Validation ●
Design Validation was performed to verify that the LaparoLight™ Veress Needle product can operate as intended. Validation test included puncturing of simulated tissue, operation of blunt tip position indicator, saline and gas delivery. -
LaparoLightTM Veress Needle Force Equivalency
Force testing was conducted to confirm that the force of the spring loaded blunt stylet and puncture force are similar to the predicate device -
LaparoLight™ Veress Needle Tip Pull Test ●
Testing to confirm equivalence to predicate device performance with regard to strength of bond between components -
LaparoLight™ Veress Needle Switch Operation Test ●
Testing to confirm equivalence to predicate device performance by testing control of gas flow with stop cock/flow controller assembly -
LaparoLight™ Veress Needle Spring Obturator Operation Test ●
Testing to confirm equivalence to predicate device performance – testing covered "click" of the needle and blunt tip extension once the needle enters open internal volume -
LaparoLight™ Veress Needle Puncture Force Test ●
Testing to confirm equivalence to predicate device performance – testing covered puncture force required to puncture tissue simulator
7. Conclusion
The performance testing demonstrates that the LaparoLight™ Veress Needle is substantially equivalent to the predicate device.