(57 days)
No
The summary describes a mechanical surgical instrument (trocar) and its performance testing, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
This device is a surgical instrument used to create a path for other instruments. It does not directly treat a disease or condition, but rather facilitates a surgical procedure.
No
The device, a disposable laparoscopic trocar, is used to establish a path for surgical instruments during minimally invasive procedures. Its function is to facilitate access for surgical tools, not to diagnose a condition.
No
The device description clearly outlines physical components (puncture needle, puncture sleeve, injection valve, sealing cover) and the performance studies describe bench tests and in vivo studies on these physical components, 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 path of entry for endoscopic instruments" during surgical procedures. This is a surgical tool used in vivo (within the body) to facilitate a procedure, not to perform a diagnostic test on a sample taken in vitro (outside the body).
- Device Description: The description details a physical instrument for creating an access point during surgery. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The proposed devices are available in two types, bladeless type and bladed type, which consist of puncture needle, puncture sleeve, injection valve and sealing cover. In order to obtain access to the surgical site during laparoscopic surgery, the puncture needle is introduced into puncture sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the injection valve at its proximal end and once the abdominal/thoracic wall is puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. The bladeless type disposable laparoscopic trocar is available in 5mm, 10mm, 12mm four diameters, and the bladed type disposable laparoscopic trocar is available in 5mm, 10mm and 12mm three diameters to accommodate different sizes surgical instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals; USP Bacterial Endotoxin Limit; ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials; ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection; ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems; ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity; ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization; ISO 10993-11:2017 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity; USP Pyrogen Test (USP Rabbit Test).
Bench tests were conducted on the proposed device and predicate device, which include Instrument Insertion and Removal Forces Test, Leak Resistance Test, Snap Feature Retention Force Test.
An in vivo study was conducted on both proposed device and predicate device, it was tested on a porcine model to evaluate the penetration force and fixation force. In addition, visual inspection was performed to check the device integrity after the trocar was removed.
Biocompatibility tests were conducted on the proposed device, the test items include Cytotoxicity test, Intracutaneous Reactivity test, Skin Sensitization test, Acute System Toxicity test and Pyrogen Test.
Sterilization and sterile barrier package testing were performed on the proposed device, which include EO and ECH residue test, Endotoxin Limit test, Visual Inspection, Seal Strength, Dye Penetration, Simulated Distribution.
No clinical study is included in this submission.
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 8, 2023
Changzhou Ankang Medical Instruments Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K231042
Trade/Device Name: Disposable Laparoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 11, 2023 Received: April 12, 2023
Dear Ms. Hong:
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.
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
1
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,
| Mark | | | | Digitally signed by
Mark Trumbore -S | |
|--------------------------------------------------|--|--|--|-----------------------------------------|--|
| Trumbore -S Date: 2023.06.08
09:51:47 -04'00' | | | | | |
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231042
Device Name Disposable laparoscopic trocar
The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K231042
-
- Date of Preparation: 06/07/2023
-
- Sponsor Identification
Changzhou Ankang Medical Instruments Co., Ltd.
A4 standard workshop, Hutang science and technology industrial park, Hutang town, Wujin district, Changhou, China 213162 Establishment Registration Number: 3009273652
Contact Person: Tingting Cao Position: Export manager Tel: +86-519-68021374 Fax: +86-519-68021367 Email: caotingting@czakyl.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Disposable laparoscopic trocar Common Name: Disposable Trocar/Cannula
Regulatory Information
Classification Name: laparoscope, general & plastic surgery Classification: II; Product Code: GCJ; Regulation Number: 21 CFR 876.1500 Review Panel: General & Plastic Surgery;
Indications for Use:
The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Device Description:
The proposed devices are available in two types, bladeless type and bladed type, which consist of puncture needle, puncture sleeve, injection valve and sealing cover. In order to obtain access to the surgical site during laparoscopic surgery, the puncture needle is introduced into puncture sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the injection valve at its proximal end and once the abdominal/thoracic wall is puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. The bladeless type disposable laparoscopic trocar is available in 5mm, 10mm, 12mm four diameters, and the bladed type disposable laparoscopic trocar is available in 5mm, 10mm and 12mm three diameters to accommodate different sizes surgical instrument.
న్. Identification of Predicate Device
510(k) Number: K190029
Product Name: Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
5
-
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals:
-
USP Bacterial Endotoxin Limit
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity:
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
ISO 10993-11:2017 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
-
USP Pyrogen Test (USP Rabbit Test)
Bench tests were conducted on the proposed device and predicate device, which include
-
Instrument Insertion and Removal Forces Test
-
Leak Resistance Test
-
Snap Feature Retention Force Test
An in vivo study was conducted on both proposed device and predicate device, it was tested on a porcine model to evaluate the penetration force and fixation force. In addition, visual inspection was performed to check the device integrity after the trocar was removed.
Biocompatibility tests were conducted on the proposed device, the test items include Cytotoxicity test, Intracutaneous Reactivity test, Skin Sensitization test, Acute System Toxicity test and Pyrogen Test.
Sterilization and sterile barrier package testing were performed on the proposed device, which include
- A EO and ECH residue test
-
Endotoxin Limit test
-
Visual Inspection
-
Seal Strength
-
Dye Penetration
-
Simulated Distribution
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Summary of Technological characteristics
| Item | Proposed Device | Predicate Device K190029
Disposable Bladeless Trocar | Remark |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Product Code | GCJ | GCJ | Same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | II | Same |
| Indications for Use | The disposable laparoscopic
trocar has applications in
abdominal and gynecologic
minimally invasive surgical
procedures to establish a path of
entry for endoscopic
instruments. | The device has applications in
abdominal, thoracic, and
gynecologic minimally invasive
surgical procedures to establish
a path of entry for endoscopic
instruments. | Different 1 |
| Configuration | Puncture Needle
Sheath
Puncture Sleeve
Protection Fixed Seat | Puncture Needle
Puncture Sleeve
Reducer Cap | Different 2 |
| Single Use | Single Use | Single Use | Same |
| Operation Mode | Manually | Manually | Same |
| Safety features | No safety feature | No safety feature | Same |
| Label/Labeling | Comply with 21, CFR Section
801 | Comply with 21, CFR Section
801 | Same |
| Shaft Diameter | Available in 5, 10, 12 and 15mm | Available in 3, 5, 8, 10, 12, and
15mm | Different 3 |
| Shaft Length | Available in 100mm | Available in 75 and 100mm | |
| Patient Contacting
component | Puncture Needle
Puncture Sleeve | Puncture Needle
Puncture Sleeve | Same |
| Patient Contacting
Material | PC, ABS, Stainless Steel | ABS | Different 4 |
| Sterilization
Method | EO sterilized | EO sterilized | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf Life | 3 years | 2 years | Different 5 |
| Packaging method | Sealing method | Sealing method | Same |
| Biocompatibility | | | |
| Table 1 | Comparison of Disposable Bladeless Trocar | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| --------- | -- | -- | ------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
7
| Intracutaneous
| Reactivity | No intracutaneous reactivity | No intracutaneous reactivity |
|---|---|---|
| Sensitization | No sensitization | No sensitization |
| Acute System | ||
| Toxicity | No acute system Toxicity | / |
| Pyrogen | No pyrogen | No pyrogen |
| Item | Proposed Device | Predicate Device K190029
Disposable Bladed Trocar | Remark |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Product Code | GCJ | GCJ | Same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | II | Same |
| Indication for Use | The disposable laparoscopic
trocar has applications in
abdominal and gynecologic
minimally invasive surgical
procedures to establish a path of
entry for endoscopic instruments. | The device has applications in
abdominal, thoracic, and
gynecologic minimally invasive
surgical procedures to establish a
path of entry for endoscopic
instruments. | Different
6 |
| Configuration | Puncture Needle
Sheath
Puncture Sleeve
Protection Fixed Seat
Blade | Puncture Needle
Puncture Sleeve
Reducer Cap
Puncture Knife | Different
7 |
| Single Use | Single Use | Single Use | Same |
| Operation Mode | Manually | Manually | Same |
| Label/Labeling | Comply with 21, CFR Section
801 | Comply with 21, CFR Section
801 | Same |
| Shaft Diameter | Available in 5, 10 and 12mm | Available in 5, 8, 10 and 12mm | Different |
| Shaft Length | Available in 100mm | Available in 75 and 100mm | 8 |
| Patient Contacting
component | Puncture Needle
Puncture Sleeve
Blade | Puncture Needle
Puncture Sleeve
Puncture Knife | Same |
| Patient Contacting
Material | PC, ABS, Stainless Steel | ABS, Stainless Steel | Different
9 |
| Sterilization
Method | EO sterilized | EO sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
Table 2 Comparison for Disposable Bladed Trocar
8
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
|---|---|---|---|
| Shelf Life | 3 years | 2 years | Different |
| 10 | |||
| Packaging method | Sealing method | Sealing method | Same |
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Intracutaneous | |||
| Reactivity | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Acute System | |||
| Toxicity | No acute system Toxicity | / | |
| Pyrogen | No pyrogen | No pyrogen |
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device K190029.