(57 days)
The disposable laparoscopic trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
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.
This document describes the premarket notification (510(k)) for a Disposable Laparoscopic Trocar and its substantial equivalence to a predicate device, K190029. The information provided is primarily focused on demonstrating this equivalence through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's main function (e.g., specific force thresholds for insertion or leak rates). Instead, it lists various standard tests and their reported outcomes, or states that the proposed device performed similarly to the predicate. The "acceptance criteria" are implied by compliance with these standards and comparable performance to the predicate device.
| Test / Performance Metric | Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-7, 10993-5, 10993-10, 10993-11, and USP <151> | No cytotoxicity, no intracutaneous reactivity, no sensitization, no acute systemic toxicity, no pyrogen |
| Ethylene Oxide (EO) Sterilization Residuals | Compliance with ISO 10993-7 | Met requirements for EO and ECH residue |
| Bacterial Endotoxin Limit | Compliance with USP <85> (20 EU per device) | Met the limit of 20 EU per device |
| Seal Strength of Flexible Barrier Materials | Compliance with ASTM F88/F88M-15 | Performed testing |
| Detecting Seal Leaks in Porous Medical Packaging | Compliance with ASTM F1929-15 | Performed testing |
| Determining Integrity of Seals (Visual Inspection) | Compliance with ASTM F1886/F1886M-16 | Performed testing |
| Performance Testing of Shipping Containers and Systems | Compliance with ASTM D4169-16 | Performed testing |
| Instrument Insertion and Removal Forces | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Leak Resistance | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Snap Feature Retention Force | Comparable to predicate device (implied) | Bench tests conducted, performed comparably to predicate device |
| Penetration Force (in vivo) | Comparable to predicate device (implied) | Evaluated on a porcine model, performed comparably to predicate device |
| Fixation Force (in vivo) | Comparable to predicate device (implied) | Evaluated on a porcine model, performed comparably to predicate device |
| Device Integrity after Removal (in vivo) | No issues (implied) | Visual inspection performed, device integrity maintained |
| Sterility Assurance Level (SAL) | $10^{-6}$ | Achieved $10^{-6}$ |
| Shelf Life | Acceptable for a medical device (stated as 3 years, predicate was 2 years) | 3 years |
| Indications for Use (scope) | Abdominal and gynecologic minimally invasive surgical procedures (for proposed device) | Covers abdominal and gynecologic minimally invasive surgical procedures |
| Shaft Diameter (Bladeless) | Available in 5mm, 10mm, 12mm, 15mm (proposed) | Available in 5mm, 10mm, 12mm, 15mm |
| Shaft Diameter (Bladed) | Available in 5mm, 10mm, 12mm (proposed) | Available in 5mm, 10mm, 12mm |
| Shaft Length | Available in 100mm (proposed) | Available in 100mm |
| Other Device Characteristics (Product Code, Regulation No., Class, Single Use, Operation Mode, Safety features, Label/Labeling, Packaging method) | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., bench tests for insertion force, or the number of porcine models used for the in vivo study). It states that "Bench tests were conducted on the proposed device and predicate device" and "An in vivo study was conducted on both proposed device and predicate device".
- Test Set Sample Size: Not explicitly stated for each test type. The term "test set" as typically used for AI/clinical studies isn't directly applicable here, as it's a medical device undergoing performance and safety testing.
- Data Provenance:
- Bench Tests: Likely conducted in a laboratory setting, presumably by the manufacturer or a contract testing organization. No country of origin is explicitly stated, but the manufacturer is Changzhou Ankang Medical Instruments Co., Ltd. in China.
- In vivo study: Conducted on a "porcine model". No country of origin is explicitly stated for the in vivo study.
- Biocompatibility, Sterilization, and Packaging tests: Conducted according to international and US standards (ISO, ASTM, USP). The specific testing facilities are not mentioned.
- Retrospective or Prospective: These are non-clinical studies and simulations, not clinical studies involving human patient data, so the terms "retrospective" or "prospective" do not apply in the typical sense. They are prospective tests designed to evaluate device performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A). This document is for a traditional medical device (Disposable Laparoscopic Trocar), not an AI/Machine Learning diagnostic device. Therefore, there's no "ground truth" derived from expert consensus on medical images or patient data in the context of an "AI test set." The evaluations are based on objective physical measurements, material properties, and biological responses as per established standards for medical devices.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. There is no ambiguous "ground truth" derived from multiple interpretations that would require an adjudication method like 2+1 or 3+1. The tests involve quantifiable measurements or pass/fail criteria against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
This information is not applicable (N/A). This device is a physical surgical instrument (trocar), not an AI diagnostic/interventional algorithm. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
This information is not applicable (N/A) for the same reason as points 3 and 5. There is no algorithm to be evaluated in a standalone or human-in-the-loop context.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI studies (e.g., pathology, outcomes data) is not directly applicable here. For this medical device, the "ground truth" or reference standards are:
- Standardized Test Methods: Adherence to established international and national standards (ISO, ASTM, USP) for material properties, sterility, biocompatibility, and packaging integrity.
- Predicate Device Performance: The predicate device K190029 serves as a benchmark for comparable performance in mechanical tests (insertion/removal forces, leak resistance, fixation force) and in vivo studies.
- Objective Measurements: Directly measured physical properties and biological responses during the bench and in vivo tests.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no AI algorithm being developed; therefore, there is no "training set" in the context of machine learning. The device development would have involved iterative design and testing, but not in the sense of an ML training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as point 8.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Mark | Digitally signed byMark Trumbore -S | ||||
|---|---|---|---|---|---|
| Trumbore -S Date: 2023.06.0809:51:47 -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
-
- 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
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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
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Simulated Distribution
-
- 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 K190029Disposable 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 laparoscopictrocar has applications inabdominal and gynecologicminimally invasive surgicalprocedures to establish a path ofentry for endoscopicinstruments. | The device has applications inabdominal, thoracic, andgynecologic minimally invasivesurgical procedures to establisha path of entry for endoscopicinstruments. | Different 1 |
| Configuration | Puncture NeedleSheathPuncture SleeveProtection Fixed Seat | Puncture NeedlePuncture SleeveReducer 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 Section801 | Comply with 21, CFR Section801 | Same |
| Shaft Diameter | Available in 5, 10, 12 and 15mm | Available in 3, 5, 8, 10, 12, and15mm | Different 3 |
| Shaft Length | Available in 100mm | Available in 75 and 100mm | |
| Patient Contactingcomponent | Puncture NeedlePuncture Sleeve | Puncture NeedlePuncture Sleeve | Same |
| Patient ContactingMaterial | PC, ABS, Stainless Steel | ABS | Different 4 |
| SterilizationMethod | 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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| IntracutaneousReactivity | No intracutaneous reactivity | No intracutaneous reactivity |
|---|---|---|
| Sensitization | No sensitization | No sensitization |
| Acute SystemToxicity | No acute system Toxicity | / |
| Pyrogen | No pyrogen | No pyrogen |
| Item | Proposed Device | Predicate Device K190029Disposable 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 laparoscopictrocar has applications inabdominal and gynecologicminimally invasive surgicalprocedures to establish a path ofentry for endoscopic instruments. | The device has applications inabdominal, thoracic, andgynecologic minimally invasivesurgical procedures to establish apath of entry for endoscopicinstruments. | Different6 |
| Configuration | Puncture NeedleSheathPuncture SleeveProtection Fixed SeatBlade | Puncture NeedlePuncture SleeveReducer CapPuncture Knife | Different7 |
| Single Use | Single Use | Single Use | Same |
| Operation Mode | Manually | Manually | Same |
| Label/Labeling | Comply with 21, CFR Section801 | Comply with 21, CFR Section801 | 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 Contactingcomponent | Puncture NeedlePuncture SleeveBlade | Puncture NeedlePuncture SleevePuncture Knife | Same |
| Patient ContactingMaterial | PC, ABS, Stainless Steel | ABS, Stainless Steel | Different9 |
| SterilizationMethod | 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 | Different10 |
| Packaging method | Sealing method | Sealing method | Same |
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| IntracutaneousReactivity | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Acute SystemToxicity | 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.
§ 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.