(114 days)
The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
The provided document is a 510(k) summary for a medical device (Trocar), not a study proving an AI device meets acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and non-clinical performance testing. Therefore, it does not contain the information requested about acceptance criteria, test sets, expert involvement, and statistical analyses typical for AI/ML device validation studies.
Specifically, the document does not provide information on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for a test set (it mentions in-house non-clinical tests, but not a large-scale clinical test set for AI).
- Data provenance for a test set.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human readers improving with AI assistance.
- Standalone performance of an algorithm (as it's a physical device).
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set (not an AI/ML device).
- How ground truth for a training set was established.
Instead, the document states:
Acceptance Criteria & Device Performance (for the physical Trocar device):
-
Acceptance Criteria (Implied): The device is expected to meet various performance requirements related to its function, biocompatibility, and sterilization. Specifically, the document mentions:
- Biocompatibility as per ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity).
- Sterilization validation per ISO 11135:2014.
- Specific performance aspects: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, Trocar Insertion/Removal force.
-
Reported Device Performance: The document states, "All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide specific numerical or qualitative results for each criterion; rather, it makes a general statement of compliance.
Study Proving Device Meets Acceptance Criteria:
- Type of Study: Non-clinical testing (bench testing, biocompatibility testing, sterilization validation). This is conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
- Sample Size Used for Test Set: Not specified. The document only mentions that "a series of tests were performed" and "The performance testing conducted on subject device is listed below." No quantitative sample sizes for these tests are provided.
- Data Provenance: Implied to be in-house testing conducted by the manufacturer in China, as per their address. It's non-clinical, so "retrospective or prospective" is not directly applicable in the same way it would be for patient data.
- Number of Experts/Qualifications & Adjudication Methods: Not applicable, as this is a physical medical device undergoing bench and biocompatibility testing, not an AI/ML assessment involving human interpretation of data.
- MRMC Comparative Effectiveness Study/Standalone Performance: Not applicable for a physical surgical instrument.
- Type of Ground Truth: The ground truth for this device's performance is objective measurements against established engineering specifications, biocompatibility standards (e.g., ISO 10993), and sterilization standards (e.g., ISO 11135).
- Training Set/Ground Truth for Training Set: Not applicable, as this is not an AI/ML device.
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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.
October 27, 2017
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Haobin Li General Manager Tang Jiao XingWang Street, LiLin Town Zhongkai Hi-Tech Zone HuiZhou, GuangDong, China 516000
Re: K172038/S001
Trade/Device Name:Trocar, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 21, 2017 Received: September 26, 2017
Dear Haobin Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (ifknown)
K172038
Device Name
Trocar, models: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar
Indications for Use (Describe)
The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port 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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements 21 CFR §807.92.
Type of submission: Traditional
The assigned 510(K) number is: K172038
The date the summary was prepared: September 20 ,2017
1. Submitter information:
Manufacturer Name: WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd.
Address: TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
Establishment Registration Number:3010601992
2. Contact person:
Haobin Li (General Manager)
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd
TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel: 0086-0752-3860807
Fax: 0086-0752-3863017
E-mail: mac_lai@wickimed.com
3. Identification of the Device
Trade Name: Trocar
Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar Common Name: Disposable Surgical Trocar /Cannula Classification Name: Laparoscope, General & Plastic Surgery Regulation Number: 876.1500 Device Classification: II Product Code: GCJ
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4. Identification of the Predicative Device
| Device Name | Common Name | Manufacturer | Classification and Code | Classification regulation | 510(k) number |
|---|---|---|---|---|---|
| UnimicroTrocar Kit | DisposableSurgicalTrocar/Cannula | UnimicroMedicalSystems(ShenZhen)Co., Ltd. | Class II ,GCJ | 21CFR876.1500 | K141594 |
| UnimaxTrocarSystem | DisposableSurgicalTrocar/Cannula | UnimaxMedicalSystems Inc. | Class II ,GCJ | 21CFR876.1500 | K112358 |
Table 1: Predicative Device Information
5. Intended Use and Indications for Use of the subject device
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
6. Device Description
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a
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port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
7. Substantial Equivalence Determination
The Trocar submitted in this 510(k) file is substantially equivalent to the cleared Unimicro Trocar Kit (K141594) and Unimax Trocar System( K112358).
The comparison to the predicate device is provided below in Table 2.
| Item | Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Trocar | Unimicro Trocar KitK141594 | Unimax Trocar SystemK112358 | ||
| Classificationregulation | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | |
| Classificationand Code | Class II ,GCJ | Class II ,GCJ | Class II ,GCJ | |
| CommonName | Disposable SurgicalTrocar /Cannula | Disposable SurgicalTrocar /Cannula | Disposable SurgicalTrocar /Cannula | |
| Indicationsfor Use | Applicate in a varietyof endoscopicprocedures toprovide a port ofentry for endoscopic | Applicate in a varietyof endoscopicprocedures to providea port of entry forendoscopic | Applicate in a varietyof endoscopicprocedures to providea port of entry forendoscopic | |
| instruments. | instruments. | instruments. | ||
| Principles ofoperation | Trocar inserted intothe skin incision, andpunctured into theabdominal cavity.Removed the | Trocar inserted intothe skin incision, andpunctured into theabdominal cavity.Removed the | Trocar inserted intothe skin incision, andpunctured into theabdominal cavity.Removed the | |
| puncture cone andmade a surgicalchannel. | puncture cone andmade a surgicalchannel. | puncture cone andmade a surgicalchannel. | ||
| Model | Auto-Locking Trocar | Auto-Locking Trocar | / | |
| Bladeless Trocar | Bladeless Trocar | / | ||
| Visible Trocar | / | Visible Trocar | ||
| Mainly | Cannula,(blade), | Cannula , (blade), | Cannula, universal | |
| Structure | universal seal, valve, | universal seal, valve, | seal, valve, stopcock | |
| stopcock | stopcock | |||
| Specification | Diameter :5-12mm | Diameter :5-12mm | Diameter :3-15mm | |
| Length :100mm | Length :70-120mm | Length :65-150mm | ||
| Technology | The built-in universal | The built-in universal | The built-in universal | |
| Characteristic | seal design for Trocar | seal design for Trocar | seal design for Trocar | |
| 10 mm and 12mm | 10 mm and 12mm and | 10 mm and 12mm | ||
| and without the use | without the use of a | and without the use | ||
| of a converter. | converter. | of a converter. | ||
| Patient-contactingstructure | ATR | Blade, Cuttinghead ,Cannula | Blade, Cuttinghead ,Cannula | / |
| BTR | Cutting head ,Cannula | Cutting head ,Cannula | / | |
| VTR | Cutting head ,Cannula | / | Cutting head ,Cannula | |
| Patient-contactingMaterials | ATR | Stainless Steel,PC,ABS | Stainless Steel,PC,ABS | / |
| BTR | PC,ABS | PC,ABS | / | |
| VTR | PC | / | PC | |
| Safetystandards | ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-11ISO 10993-12ISO 11135 | ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12ISO 11135-1 | ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12ISO 11135-1 | |
| Performancetesting items | ObturatorcompatibilityInsertion & cannulastabilityAir leakageTrocar Insertion/Removal force | ObturatorcompatibilityInsertion & cannulastabilityAir leakage/ | ObturatorcompatibilityInsertion & cannulastabilityAir leakage/ | |
| Sterilization | EO Sterilized | EO Sterilized | EO Sterilized |
Table 2 : Comparison to Predicate Device
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WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
The subject and predicate device have the same intended use. The subject and predicate device designs are nearly identical. Both are single-use devices and structure and technology characteristic are identical. The differences in specification between the subject and predicate devices do not raise different questions of safety and effectiveness.
8. Non-clinical Testing
A series of tests were performed to assess the safety and effectiveness of the Trocar. Biocompatibility tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization validation was performed per ISO 11135:2014.
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The tests listed below evaluated the performance of the subject device.
The performance testing conducted on subject device is listed below:
- Obturator Compatibility ●
- Insertion & Cannula Stability ●
- Air Leakage
- Trocar Insertion/ Removal force
All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses.
9. Conclusion
Based on the results of the above described performance testing data, it can be concluded that the Trocar is as safe and effective as the predicate devices.
§ 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.