Disposable Laparoscopic Trocar

K231042 · Changzhou Ankang Medical Instruments Co., Ltd. · GCJ · Jun 8, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231042
• Device Name: Disposable Laparoscopic Trocar
• Applicant: Changzhou Ankang Medical Instruments Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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 Story

Disposable laparoscopic trocar (bladeless or bladed) facilitates access to surgical sites during minimally invasive procedures. Device consists of puncture needle, puncture sleeve, injection valve, and sealing cover. Surgeon manually introduces puncture needle through sleeve to penetrate abdominal wall; needle is removed, leaving sleeve as channel for endoscopes and surgical instruments. Used in clinical settings by surgeons. Device provides stable entry path, enabling visualization and instrument manipulation. Benefits include minimally invasive access, reducing trauma compared to open surgery. Materials include PC, ABS, and stainless steel. Sterilized via ethylene oxide.

Clinical Evidence

No clinical data. Bench testing included instrument insertion/removal forces, leak resistance, and snap feature retention. In vivo porcine study evaluated penetration and fixation forces. Biocompatibility testing (cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, pyrogenicity) and sterilization/packaging validation (EO residuals, seal strength, dye penetration) were performed.

Technological Characteristics

Materials: PC, ABS, stainless steel. Operation: Manual. Sterilization: Ethylene Oxide (SAL 10^-6). Configuration: Puncture needle, sleeve, injection valve, sealing cover. Diameters: 5mm, 10mm, 12mm. Standards: ISO 10993-5/7/10/11, USP <85>/<151>, ASTM F88/F1929/F1886/D4169.

Indications for Use

Indicated for patients undergoing abdominal or gynecologic minimally invasive surgical procedures requiring a path of entry for endoscopic instruments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar (K190029)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

| Mark | | | | Digitally signed by<br>Mark Trumbore -S | |
|--------------------------------------------------|--|--|--|-----------------------------------------|--|
| Trumbore -S Date: 2023.06.08<br>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

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### 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)

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# 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

- 1. Date of Preparation: 06/07/2023
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)

### Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 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:

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- > ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals:
- > USP <85> 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 <151> 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
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 8. Summary of Technological characteristics

| Item | Proposed Device | Predicate Device K190029<br>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<br>trocar has applications in<br>abdominal and gynecologic<br>minimally invasive surgical<br>procedures to establish a path of<br>entry for endoscopic<br>instruments. | The device has applications in<br>abdominal, thoracic, and<br>gynecologic minimally invasive<br>surgical procedures to establish<br>a path of entry for endoscopic<br>instruments. | Different 1 |
| Configuration | Puncture Needle<br>Sheath<br>Puncture Sleeve<br>Protection Fixed Seat | Puncture Needle<br>Puncture Sleeve<br>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<br>801 | Comply with 21, CFR Section<br>801 | Same |
| Shaft Diameter | Available in 5, 10, 12 and 15mm | Available in 3, 5, 8, 10, 12, and<br>15mm | Different 3 |
| Shaft Length | Available in 100mm | Available in 75 and 100mm | |
| Patient Contacting<br>component | Puncture Needle<br>Puncture Sleeve | Puncture Needle<br>Puncture Sleeve | Same |
| Patient Contacting<br>Material | PC, ABS, Stainless Steel | ABS | Different 4 |
| Sterilization<br>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 | | | | | | | | | | | |
|---------|--|--|-------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|
|---------|--|--|-------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|

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| Intracutaneous<br>Reactivity | No intracutaneous reactivity | No intracutaneous reactivity |
|------------------------------|------------------------------|------------------------------|
| Sensitization | No sensitization | No sensitization |
| Acute System<br>Toxicity | No acute system Toxicity | / |
| Pyrogen | No pyrogen | No pyrogen |

| Item | Proposed Device | Predicate Device K190029<br>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<br>trocar has applications in<br>abdominal and gynecologic<br>minimally invasive surgical<br>procedures to establish a path of<br>entry for endoscopic instruments. | The device has applications in<br>abdominal, thoracic, and<br>gynecologic minimally invasive<br>surgical procedures to establish a<br>path of entry for endoscopic<br>instruments. | Different<br>6 |
| Configuration | Puncture Needle<br>Sheath<br>Puncture Sleeve<br>Protection Fixed Seat<br>Blade | Puncture Needle<br>Puncture Sleeve<br>Reducer Cap<br>Puncture Knife | Different<br>7 |
| Single Use | Single Use | Single Use | Same |
| Operation Mode | Manually | Manually | Same |
| Label/Labeling | Comply with 21, CFR Section<br>801 | Comply with 21, CFR Section<br>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<br>component | Puncture Needle<br>Puncture Sleeve<br>Blade | Puncture Needle<br>Puncture Sleeve<br>Puncture Knife | Same |
| Patient Contacting<br>Material | PC, ABS, Stainless Steel | ABS, Stainless Steel | Different<br>9 |
| Sterilization<br>Method | EO sterilized | EO sterilized | Same |
| SAL | 10-6 | 10-6 | Same |

Table 2 Comparison for Disposable Bladed Trocar

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| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
|------------------------------|------------------------------|------------------------------|-----------------|
| Shelf Life | 3 years | 2 years | Different<br>10 |
| Packaging method | Sealing method | Sealing method | Same |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Intracutaneous<br>Reactivity | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Acute System<br>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.