(59 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML components or data processing.
No
The device is used to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery, not a therapeutic intervention itself.
No
The device is used for insufflation with carbon dioxide to establish pneumoperitoneum, which is a preparatory step for laparoscopic procedures, not for diagnosing a condition.
No
The device description clearly outlines a physical medical device with components like needles, a spring, handle, and valve, and its function is based on a mechanical mechanism. There is no mention of software as a component or primary function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures." This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device used for insertion into the body. It does not describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Information: The device's function is purely mechanical – to create space in the peritoneal cavity. It does not analyze any biological samples or provide any diagnostic information about the patient's health.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, shelf life, and physical performance of the needle itself. They do not involve evaluating the device's ability to detect or measure substances in biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to help diagnose or monitor medical conditions. This device is a surgical instrument used directly on the patient's body during a procedure.
N/A
Intended Use / Indications for Use
The GTK Veress Needles are 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 structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm).
The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.
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
hospital setting/environment
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 test: The needle (inner and outer) of the GTK Veress Needles are contacting with abdominal skin and abdominal wall tissue of human for less than 24 hours. The following tests were conducted: ISO 10993-5: 2009-In Vitro Cytotoxicity test; ISO 10993-10: 2010-Skin Sensitization test and Intracutaneous reactivity test; ISO 10993-11: 2006- Acute systemic toxicity and Pyrogen test; USP 39 -Bacterial endotoxin test.
- Sterilization validation: The sterilization validation was conducted according to ISO 11135:2014. The EO and ECH residual of the proposed device was evaluated by ISO 10993-7:2008.
- Shelf life validation test: The package verification test on proposed devices were conducted after accelerated aging for 3 years (ASTM F 1980-07 (2011)): ISO 11737-2:2009-sterility test; ASTM D 3078-02:2013-vacuum leak test; ASTM F 88-seal strength test; ASTM F 1929-12-leakage (dye penetration test); Din 58953-6:2010-microbial barrier properties (agar contact-attack test); And physical performance of the proposed device was conducted after natural aging. All the results meet the acceptance criteria.
- Performance test-bench: The performance tests of GTK Veress Needles contain appearance, size, tip pull test, switch operation test, spring obturator operation and needle puncture force test. All the results meet the acceptance criteria. they also demonstrate that the GTK Veress Needles meet the performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 30, 2020
Guangzhou T.K Medical Instrument Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town, Nanshan District, Shenzhen Guangdong Province, 518000 CHINA
K193339 Trade/Device Name: GTK Veress Needles Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, FHO Dated: December 2, 2019 Received: December 2, 2019
Dear Christy Young:
Re:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Sharon M. Andrews Acting Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193339
Device Name GTK Veress Needles
Indications for Use (Describe)
The GTK Veress Needles are 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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| 1. Submission Sponsor | |
|---|---|
| Applicant Name | Guangzhou T.K Medical Instrument Co., Ltd. |
| Address | A601, Guangzhou International Business Incubator |
| , Guangzhou Science Park, Guangzhou, Guangdong, P. R. China | |
| Post Code | 510663 |
| Phone No. | +86-20-32290169 |
| Fax No. | +86-20-32290395 |
| Contact Person | Ms. Tracy Weng |
| Date Prepared | 1-28-2020 |
510(k) Summary
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong, P.R.China |
| Image: [logo] | |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Ms. Christy Young; Field Fu |
| christy@cefda.com; |
3. Devices Identification
| Trade Name | GTK Veress Needles |
|---|---|
| Common Name | Veress Needle |
| Model Names | VN-120 and VN-150 |
| Regulatory Class | II |
| Classification Name | Laparoscopic insufflator |
| Classification Number | 21 CFR 884.1730 |
| Product Code | HIF; FHO |
| Product Code Name | Insufflator, Laparoscopic; Pneumoperitoneum |
| Needle | |
| 510(k) review panel | Obstetrics/Gynecology; Gastroenterology/Urology |
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4. Leqally Marketed Predicate Devices
| Trade Name | Veress Needle |
|---|---|
| Classification Number | 21 CFR 884.1730 |
| Classification Name | Laparoscopic insufflator |
| Regulatory Class | II |
| 510 (k) number | K172120 |
| Product Code | HIF; FHO |
| Product Code Name | Insufflator, Laparoscopic; Pneumoperitoneum Needle |
| Manufacturer | WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. |
The predicate device was not subject to a design-related recall.
5. Legally Marketed Reference Devices
| Trade Name | Medline Pneumoperitoneum Needle |
|---|---|
| Classification Number | 21 CFR 884.1730 |
| Classification Name | Laparoscopic insufflator |
| Regulatory Class | II |
| 510 (k) number | K111955 |
| Product Code | HIF; FHO; |
| Product Code Name | Insufflator, Laparoscopic; Pneumoperitoneum Needle |
| Manufacturer | Medline Industries, Inc |
The reference device was not subject to a design-related recall
6. Device Description
The structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm).
The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.
7. Indications for Use Statement
The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish
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pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
8. Substantial Equivalence Discussion
| Items | Proposed device | Predicate device | Comments | ||
|---|---|---|---|---|---|
| Trade name | GTK Veress Needles | Veress Needle | / | ||
| 510(K) | |||||
| submitter | Guangzhou T.K | ||||
| Medical Instrument | |||||
| Co., Ltd. | WickiMed (Huizhou) | ||||
| Medical Equipment | |||||
| Manufacturing Co., Ltd. | / | ||||
| 510(K) number | / | K172120 | / | ||
| Classification | |||||
| regulation | 21CFR 884.1730 | 21CFR 884.1730 | Same | ||
| Classification | |||||
| and product | |||||
| code | Class II , | ||||
| HIF,FHO | Class II , | ||||
| HIF,FHO | Same | ||||
| Common name | Veress Needle | Veress Needle | Same | ||
| Intended use | The GTK Veress | ||||
| Needles are 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. | The 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. | Same | ||||
| Components | Veress Needle | ||||
| Obturator | Veress Needle | ||||
| Obturator | Same | ||||
| Model | VN-120 and VN-150 | WVN0112T, WVN0115T | / | ||
| Length | 120mm,150mm | 120mm,150mm | Same | ||
| Sterilization | EO Sterilized | EO Sterilized | Same | ||
| Disposable | Yes | Yes | Same | ||
| Materials | Patient- | ||||
| contacting | |||||
| Material | |||||
| (Outer tube | |||||
| inner tube) | SUS | ||||
| 304 | Patient- | ||||
| contacting | |||||
| Material | |||||
| (Outer tube | |||||
| inner tube) | SUS | ||||
| 304 | Same | ||||
| Handle material | PC | Handle material | PC | Same | |
| Principles of operation | Connect the device to the insufflators with insufflation tubing, insufflating with carbon dioxide to establish pneumoperitoneum. | Connect the device to the insufflators with insufflation tubing, insufflating with carbon dioxide to establish pneumoperitoneum. | Same |
Table 1: Substantial equivalence comparison
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9. Non-Clinical Performance Data
1) Biocompatibility test
The needle (inner and outer) of the GTK Veress Needles are contacting with abdominal skin and abdominal wall tissue of human for less than 24 hours. The following tests were conducted:
ISO 10993-5: 2009-In Vitro Cytotoxicity test;
ISO 10993-10: 2010-Skin Sensitization test and Intracutaneous reactivity test; ISO 10993-11: 2006- Acute systemic toxicity and Pyrogen test;
USP 39 -Bacterial endotoxin test.
2) Sterilization validation
The sterilization validation was conducted according to ISO 11135:2014. The EO and ECH residual of the proposed device was evaluated by ISO 10993-7:2008.
Shelf life validation test 3)
The package verification test on proposed devices were conducted after accelerated aging for 3 years (ASTM F 1980-07 (2011)):
ISO 11737-2:2009-sterility test;
ASTM D 3078-02:2013-vacuum leak test;
ASTM F 88-seal strength test;
ASTM F 1929-12-leakage (dye penetration test);
Din 58953-6:2010-microbial barrier properties (agar contact-attack test); And physical performance of the proposed device was conducted after natural aging. All the results meet the acceptance criteria.
4) Performance test-bench
The performance tests of GTK Veress Needles contain appearance, size, tip pull test, switch operation test, spring obturator operation and needle puncture force test. All the results meet the acceptance criteria. they also demonstrate that the GTK Veress Needles meet the performance characteristics.
10. Statement of Substantial Equivalence
The Indications for Use and technological characteristics for GTK Veress Needles are same to the predicate devices (K172120). The non-clinical performance testing demonstrates that the proposed device is as safe and effective as the predicate devices. Therefore, the results show that it is Substantially Equivalent (SE) between
7
products and predicate devices.