(88 days)
Not Found
No
The device description and performance studies focus on mechanical and sterilization properties, with no mention of AI or ML.
No.
The device is used to insufflate the peritoneal cavity with carbon dioxide to establish pneumoperitoneum, which is an preparatory step for surgical procedures, not a therapeutic intervention itself.
No
The device is used for insufflation with carbon dioxide to establish pneumoperitoneum, which is a preparatory step for surgical procedures, not for diagnosing a condition.
No
The device description clearly states it is a sterile disposable Veress needle with physical components like a spring-loaded obturator and a slide switch for gas flow control. The performance studies also focus on physical characteristics and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a needle used for gas delivery into the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to assays, reagents, or diagnostic measurements.
Therefore, the InsufflatOR Needle is a surgical instrument used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InsufflatOR 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
Device Description
The Gynetech InsufflatOR Needle is a sterile disposable Veress needle which is available in 120mm or 150mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of gas flow. The most proximal end contains a male luer lock connector for connection to a CO2 gas line. The InsufflatOR Needle has applications in gynaecological laparoscopy and other laparoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
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)
The contract manufacturer, Advanced Medical, LLC, manufactures the InsufflatOR Needle to the same exact specifications as the predicate device by GeniCon. This includes specifications for:
- . Tip pull test
- . Switch operation test
- Spring obturator test
- Needle puncture force test
To evaluate the change in sterilization method, the following tests were conducted on the InsufflatOR Needle:
- EtO Sterilization Validation in accordance with ISO 11135-1:2007 Sterilisation of Healthcare Products Ethylene Oxide ●
- Ethylene Oxide Sterilisation Residuals, ISO 10993-7:2008 Biological Evaluation of Medical Devices .
- . Packaging integrity and device functional performance testing following accelerated aging.
All testing undertaken to demonstrate substantial equivalence of the requirements of its predeternined acceptance criteria and intended use. The acceptance criteria and intended use of the Gynetech Insufflat to the predicate device. These test results confirm that the Gynetech InsufflatOR Needle is as safe and effective as 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Gynetech Pty. Ltd. % Kevin MacDonald Clinical/Regulatory Consultant 229 Marvilla Circle Pacifica, CA 94044
Re: K142700 Trade/Device Name: InsufflatOR Needle, 12cm/15cm Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: November 16, 2014 Received: November 21, 2014
Dear Kevin MacDonald,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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 yours,
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
2
Section 6: Indications for Use Statement
Indications for Use
510(k) Number (if known): K142700
Device Name: InsufflatOR Needle
Indications for Use:
The InsufflatOR 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.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image contains the word "gynetec" in a sans-serif font. The first part of the word, "gyne", is in blue, while the second part, "tec", is in gray. To the right of the word is a stylized blue letter "g" surrounded by a pattern of blue dots.
Section 7: 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92(c).
| Submitted by: | Gynetech Pty Ltd |
|---|---|
| 122-124 Balmain Street, Richmond VIC 3121, Australia | |
| Phone: +61 3 9413 5555 | |
| Contact email: qa@gynetech.com.au | |
| Fax: +61 3 9413 5555 | |
| Contact Person | Kevin MacDonald |
| Clinical/Regulatory Consultant | |
| 229 Marvilla Circle | |
| Pacifica, CA 94044 | |
| Phone: 415-609-9875 | |
| Email: k-macdonald@sbcglobal.net | |
| Date Prepared: | December 17, 2014 |
| Proprietary Name: | InsufflatOR Needle |
| Common Name: | Veress Needle |
| Classification: | ll |
| Regulation Number: | 884.1730 |
| Regulation Name: | Laparoscopic insufflator |
| Panel: | Obstetrics/Gynecology |
| Product Code: | HIF |
| Predicate Devices: | GeniCon Pneumo-Needle (K993625) |
| Device Description: | The Gynetech InsufflatOR Needle is a sterile disposable Veress needle which is |
| available in 120mm or 150mm length. The device is equipped with a spring-loaded, | |
| round-tipped obturator. In addition, there is a "slide switch" which permits easy ON- | |
| OFF control of gas flow. The most proximal end contains a male luer lock connector | |
| for connection to a CO2 gas line. The InsufflatOR Needle has applications in | |
| gynaecological laparoscopy and other laparoscopic procedures. | |
| Indications for Use: | The InsufflatOR 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. | |
4
Image /page/4/Picture/0 description: The image contains the word "gynetech" in blue and gray font. The word "gyne" is in blue, and the word "tech" is in gray. To the right of the word is a blue circle made of dots with a white "g" in the center.
| Comparison of Subject Device to Predicate Device | ||||
|---|---|---|---|---|
| Attribute | InsufflatOR Needle | GeniCon Pneumo-Needle | ||
| 510(k) number | K142700 | K993625 | ||
| Regulation Number | 884.1730 | 884.1730 | ||
| Classification | Class II | Class II | ||
| Classification Name | Insufflator, Laparoscopic | Insufflator, Laparoscopic | ||
| Product Code and | ||||
| Classification Panel | HIF | |||
| Obstetrics/Gynecology Panel | HIF | |||
| Obstetrics/Gynecology Panel | ||||
| Manufacturer | Advanced Medical Design International LLC (see Establishment | |||
| Registration Details in Attachment 5) | Same | |||
| Description | The Gynetech InsufflatOR Needle is a sterile and single use | |||
| product. It incorporates a spring loaded blunt style mechanism. | ||||
| It is used to establish pneumoperitoneum prior to trocar and | ||||
| cannula insertion during laparoscopic procedures. The | ||||
| InsufflatOR Needle is available in 120mm and 150mm lengths | ||||
| and has applications in gynaecological laparoscopy and other | ||||
| laparoscopic procedures. | The GeniCon Pneumo-Needle is a sterile disposable | |||
| Veress needle which is available in 120mm or | ||||
| 150mm length. The device is equipped with a spring- | ||||
| loaded, round-tipped obturator. In addition, there is | ||||
| a "slide switch" which permits easy ON-OFF control | ||||
| of gas flow. The most proximal end contains a male | ||||
| luer lock connector for connection to a CO2 gas line. | ||||
| Indications for Use | The InsuffaltOR 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. | Same | |||
| Anatomical sites | Abdominal | Same | ||
| Consisted Instruments | Veress Needle | |||
| Obturator | Same | |||
| Materials | Hub - Model grade PC | |||
| Gas Trap - High density Polyethylene (HDPE) | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for "Gynetech". The word "gyne" is in blue, and the word "tech" is in gray. To the right of the word is a blue circle made of dots, with a white "g" in the center.
| Comparison of Subject Device to Predicate Device | ||
|---|---|---|
| Attribute | InsufflatOR Needle | GeniCon Pneumo-Needle |
| Shaft - Stainless Steel 304 (Inner shaft 1.6135 / Outer shaft 2.1131) | ||
| Spring - Stainless steel and ABS pink | ||
| Dimensions | Length: 120mm or 150mm | Same |
| Performance Standards | Not Applicable | Not Applicable |
| Sterilization method | Ethylene Oxide | Gamma radiation |
| Packaging | Tyvek pouch | Same |
Performance Data
The contract manufacturer, Advanced Medical, LLC, manufactures the InsufflatOR Needle to the same exact specifications as the predicate device by GeniCon. This includes specifications for:
- . Tip pull test
- . Switch operation test
- Spring obturator test
- Needle puncture force test
To evaluate the change in sterilization method, the following tests were conducted on the InsufflatOR Needle:
- EtO Sterilization Validation in accordance with ISO 11135-1:2007 Sterilisation of Healthcare Products Ethylene Oxide ●
- Ethylene Oxide Sterilisation Residuals, ISO 10993-7:2008 Biological Evaluation of Medical Devices .
- . Packaging integrity and device functional performance testing following accelerated aging.
Conclusion:
All testing undertaken to demonstrate substantial equivalence of the requirements of its predeternined acceptance criteria and intended use. The acceptance criteria and intended use of the Gynetech Insufflat to the predicate device. These test results confirm that the Gynetech InsufflatOR Needle is as safe and effective as the predicate device.