(51 days)
No
The summary describes a basic mechanical surgical instrument (trocar) and its performance characteristics, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
A therapeutic device is one that treats a disease or condition. This device is used to establish entry for other surgical instruments and does not directly treat a disease or condition.
No
The device is a surgical instrument (trocar) used to establish a path of entry for other endoscopic instruments during minimally invasive procedures; it does not diagnose conditions.
No
The device description and performance studies clearly indicate a physical, disposable surgical instrument (trocar) used to create a path for other instruments. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical instrument used to create a path of entry into the body for other surgical instruments during minimally invasive procedures. It is used in vivo (within the living body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on specimens.
Therefore, based on the provided information, the Disposable Laparoscope Trocar is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ
Device Description
The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four 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, thoracic, and 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 Substantially Equivalent (SE) 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 Device- Part 7: Ethylene Oxide Sterilization Residuals
- USP Bacterial Endotoxin Limit
- ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- ISO 10993-11:2017 Biological Evaluation of Medical Device- Part 11: Tests for Systemic Toxicity
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 porcine model to evaluate the penetration force, fixation force and visualization performance (for optical type only), in addition, tip integrity was also evaluated after each insertion.
Biocompatibility tests were conducted on the proposed device, the test items include Cytotoxicity test, Instracutaneous test, Skin Sensitization, 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
- Seal strength test
- Dye penetration test
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Insertion force (N)
RJTC-A5: Average 2.25
RJTC-A15: Average 4.08
Removal force (N)
RJTC-A5: Average 6.37
RJTC-A15: Average 10.31
Leak resistance
No Leakage
Snap feature retention force (N)
RJTC-A5: Average 1.8
RJTC-A15: Average 11.8
Predicate Device(s)
Reference Device(s)
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
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August 6, 2020
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K201641
Trade/Device Name: Disposable Laparoscope Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 27, 2020 Received: June 16, 2020
Dear Diana 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
1
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) 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,
Long Chen, 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) K201641
Device Name Disposable Laparoscope Trocar
The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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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: K201641
-
- Date of Preparation: 08/06/2020
-
- Sponsor Identification
Beijing Biosis Healing Biological Technology Co., Ltd.
No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600, Beijing, China.
Establishment Registration Number: 3016668451
Contact Person: Jiali Zhou Position: RA Tel: +86-10-61252660 Fax: +86-10- 61252030 Email: zhoujiali@biosishealing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan 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: +1-360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Disposable Laparoscope Trocar Common Name: General& Plastic Surgery
Regulatory Information Classification Name: Endoscope and Accessories Classification: II; Product Code: GCJ; Regulation Number: 21CFR 876.1500 Review Panel: General& Plastic Surgery;
Indication for Use:
The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description:
The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.
-
- Identification of Predicate Device
510(k) Number: K180208 Product Name: Disposable Endoscopic Trocar
- Identification of Predicate Device
-
- Identification of Reference Device
510(k) Number: K032676 Product Name: Endopath Bladeless Trocar
- Identification of Reference Device
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
5
-
USP Bacterial Endotoxin Limit
-
ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by > Dye Penetration
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
ISO 10993-11:2017 Biological Evaluation of Medical Device- Part 11: Tests for Systemic Toxicity
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 porcine model to evaluate the penetration force, fixation force and visualization performance (for optical type only), in addition, tip integrity was also evaluated after each insertion.
Biocompatibility tests were conducted on the proposed device, the test items include Cytotoxicity test, Instracutaneous test, Skin Sensitization, 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
-
Seal strength test
-
Dye penetration test
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
6
9. Substantially Equivalent (SE) Comparison
| ITEM | Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|---|
| K201641 | K180208 | K032676 | ||
| Product Code | GCJ | GCJ | GCJ | |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | |
| Class | II | II | II | |
| Indication for Use | The Disposable Laparoscope | |||
| Trocar has applications in | ||||
| abdominal, thoracic, and | ||||
| gynecologic minimally invasive | ||||
| surgical procedures to establish a | ||||
| path of entry for endoscopic | ||||
| instruments. The trocar may be | ||||
| used with or without | ||||
| visualization for primary and | ||||
| secondary insertions. | The Disposable Endoscopic | |||
| Trocar has applications in | ||||
| abdominal, thoracic, and | ||||
| gynecologic minimally invasive | ||||
| surgical procedures to establish | ||||
| a path of entry for endoscopic | ||||
| instruments. The trocar may be | ||||
| used with or without | ||||
| visualization for primary and | ||||
| secondary insertions. | The ENDOPATH Bladeless | |||
| Trocar has applications in | ||||
| abdominal, thoracic and | ||||
| gynecologic minimally | ||||
| invasive procedures to | ||||
| establish a path of entry for | ||||
| endoscopic instruments. The | ||||
| trocar may be used with or | ||||
| without visualization for | ||||
| primary and secondary | ||||
| insertions. | ||||
| Main component | Puncture Needle | |||
| Puncture sleeve | ||||
| Obstruct valve body | ||||
| Injection switch | ||||
| Injection valve | ||||
| Sealing cap | ||||
| Gas barrier seal | ||||
| Lower retaining ring | ||||
| Sealing ring | ||||
| Upper retaining ring | ||||
| Elastic seal ring | ||||
| Fixed cover | ||||
| Positioning guide cover | ||||
| Secure cover | Obturator | |||
| Obturator Handle | ||||
| Scope locking Cam (Except | ||||
| FLPC5, FLOC10, FLPC12) | ||||
| Obturator Locking Button | ||||
| (housed in obturator handle) | ||||
| Outer Seal | ||||
| Outer Seal Release Lever | ||||
| (Except FLPC5, FLPC10, | ||||
| FLPC12) | ||||
| Stopcock | ||||
| Trocar Smooth Sleeve | ||||
| Trocar Stability Sleeve | ||||
| Optical Element | ||||
| Bladeless Tip | Obturator | |||
| Sleeve | ||||
| Universal seal | ||||
| Release lever | ||||
| Camera scope-locking tab | ||||
| Recessed stopcock valve | ||||
| Bladeless optical tip | ||||
| Single Use | Single Use | Single Use | Single Use | |
| Operation Mode | Manually | Manually | Manually | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part | |
| 801 | ||||
| Diameter (mm) | Available in 5, 10, 12 and 15 | Available in 5, 10 and 12 | Available in 5, 8, 11 and 12 | |
| Length (mm) | Available in 96, 98, 99 and 111 | 100 | Available in 75, 100 and 150 | |
| Patient Contacting | ||||
| component | Obturator | Obturator | ||
| Puncture Needle | Trocar Smooth Sleeve | Sleeve | ||
| Puncture Sleeve | Optical Element | Bladeless optical tip | ||
| Bladeless Tip | ||||
| Patient Contacting | ||||
| Material | Polycarbonate (PC) | ABS-1, MN, | ||
| 095-30-16-15/PC/Stainless 12Cr | ||||
| 18Ni9/ Stainless 06Cr19Ni10 | Unknown | |||
| Biocompatibility | ||||
| Cytotoxicity | ||||
| Sensitization | Comply with ISO 10993 | |||
| standards | Comply with ISO 10993 | |||
| standards | Comply with ISO 10993 | |||
| standards | ||||
| Instracutaneous | ||||
| System Toxicity | ||||
| Pyrogen | ||||
| Insertion force (N) | RJTC-A5: Average 2.25 | |||
| RJTC-A15: Average 4.08 | BLTC12: Average 4.2 | B5LT: Average 2.35 | ||
| Removal force (N) | RJTC-A5: Average 6.37 | |||
| RJTC-A15: Average 10.31 | BLTC12: Average 10.19 | B5LT: Average 6.27 | ||
| Leak resistance | No Leakage | No Leakage | No Leakage | |
| Snap feature | ||||
| retention force (N) | RJTC-A5: Average 1.8 | |||
| RJTC-A15: Average 11.8 | BLTC12: Average 11.98 | B5LT: Average 1.69 | ||
| Sterilization | ||||
| Method | EO sterilized | Irradiation | Irradiation | |
| SAL | 10-6 | 10-6 | 10-6 | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | 20 EU per device |
Table 1 Comparison of Disposable Laparoscope Trocar
4 / 5
7
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.