(116 days)
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.
Here's an analysis of the acceptance criteria and study information for the ArtiSential Trocar based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing relative to a predicate device, focusing on equivalence rather than specific numerical acceptance criteria. The acceptance criteria for many tests are implicitly "passed the test" or "met performance requirements," indicating non-inferiority or equivalence to the predicate.
| Test Category | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Evaluation according to ISO 10993-1, specific endpoints assessed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity. Implicitly, test results should be within acceptable biological safety limits. | All assessed endpoints (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity) were evaluated. The document states "Given the favorable biocompatibility test results, the difference between raw material of proposed device and predicate device does not raise different questions in safety and effectiveness." (Implies all tests passed favorably) |
| Sterilization | EO-Sterilization in accordance with ISO-11135. Implicitly, device must be sterile and maintain sterility. | EO-Sterilization performed in accordance with ISO-11135. "The effectiveness of our sterilization method was verified through the sterilization validation test and the accelerated aging test." (Implies successful sterilization and maintenance of sterility) |
| Shelf Life | Packaging integrity (per ASTM F 88/F88M-15), Sealing strength (per ASTM F 88/F88M-15), Dye penetration (per ASTM F1929), Sterility (per ISO 11737-2), Appearance, Dimension, Leak test, Tensile Strength. All tests passed at 0 and 3 years accelerated aging. | "The device had passed all tests as below" for all listed tests at zero time point and 3 years accelerated aging point. |
| Bench Test | Appearance, Dimension, Leak test, Tensile Strength, and the ability to 1) maintain pneumoperitoneum (with and without instruments inserted) and 2) manipulate instruments for laparoscopic surgery. Implicitly, performance comparable to predicate. | "The testing was conducted side-by-side with the predicate device as following and had passed all performed tests." (Implies equivalence or non-inferiority to predicate) |
| Animal Testing | Tissue insertion and retention forces, Intra-abdominal pressure, Obturator integrity after insertion. Implicitly, performance comparable to predicate. | "The device was conducted side-by-side in vivo (micro pig, M-type) testing with the predicate device as following. The device had passed all performed tests." (Implies equivalence or non-inferiority to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench and Animal Testing: The specific sample sizes (e.g., number of devices for bench tests, number of animals for in vivo tests) are not explicitly stated in the provided text. The text only mentions that testing "was conducted side-by-side with the predicate device."
- Data Provenance:
- Bench Test: Likely conducted in a laboratory setting by the manufacturer, or a contracted testing facility. No specific country of origin is mentioned for the data itself.
- Animal Testing: Conducted "in vivo (micro pig, M-type) testing." This indicates live animal testing. No specific country of origin for the animals or the testing facility is mentioned.
- Retrospective or Prospective: These tests are by nature prospective, as they are specifically conducted to evaluate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are performance tests of a physical device, not diagnostic or interpretive studies that typically require expert-established ground truth. The "ground truth" for these tests would be the measured physical or biological outcomes.
4. Adjudication Method:
This information is not applicable/provided. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting ambiguous results in diagnostic studies, particularly when human readers are involved in establishing ground truth. The tests described here (biocompatibility, sterilization, physical performance) have objective, measurable outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert human interpretation of cases (e.g., medical images) is being augmented or replaced by AI. The ArtiSential Trocar is a physical surgical tool, not a diagnostic AI system, therefore an MRMC study is not relevant here.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone study was not done. This also applies to AI-powered diagnostic devices. The ArtiSential Trocar is a physical device, and its performance is evaluated through direct physical and biological testing, not through an algorithm.
7. Type of Ground Truth Used:
The ground truth for the performance studies is based on objective, measurable physical and biological parameters assessed during the various tests.
- For biocompatibility: Measured biological responses according to ISO 10993-1.
- For sterilization: Confirmation of sterility and packaging integrity according to ISO 11135, ASTM F 88/F88M-15, ASTM F1929, ISO 11737-2.
- For bench tests: Measured physical properties (dimensions, tensile strength, leak rate) and functional performance (pneumoperitoneum maintenance, instrument manipulation).
- For animal tests: Measured forces, pressures, and visual integrity post-insertion.
8. Sample Size for the Training Set:
This information is not applicable. The ArtiSential Trocar is a physical medical device. It does not employ artificial intelligence or machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
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December 3, 2021
LivsMed Inc. Dong Wook Lee Quality Management Representative #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 Seongnam-si, Gyeonggi-do Republic of Korea
Re: K212500
Trade/Device Name: ArtiSential Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 18, 2021 Received: October 19,2021
Dear Dong Wook Lee:
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/cfpm/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.
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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 and Part 809); medical device reporting (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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212500
Device Name ArtiSential Trocar
Indications for Use (Describe)
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive 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
1. General Information
| Applicant/Submitter: | LivsMed Inc. |
|---|---|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-4282-7652Fax) +82-31-706-3211 |
| Contact Person: | Dong Wook Lee / QMR(Quality Management Representative) |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-7709-4993Fax) +82-31-706-3211Email) dongwook.livsmed@gmail.com |
| Preparation Date: | 11-19-2021 |
2. Device Name and Code
| Device Trade Name | ArtiSential Trocar |
|---|---|
| Common Name | Sterile Trocars for Endoscopic surgery |
| Classification Name | Endoscope and accessories |
| Product Code | GCJ |
| Regulation Number | 21 CFR 876.1500 |
| Classification | Class II |
| Review Panel | General & Plastic Surgery |
3. Predicate Devices
ArtiSential Trocar is the same or similar to the device in Table 3.1.
- 3.1 Subject Device Description
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.
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The device falls within Section 876.1500 Endoscope and accessories and is a prescription use only.
Table 3.1 Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Applied Medical ResourcesCorp. | Modular Trocar System | K060096 |
4. Indications for Use
- 4.1 Indications for use
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
5. Technical Characteristics in Comparison to Predicate Devices
Table 5.1 Comparison of Proposed device and predicate device
| Proposeddevice | Predicatedevice | SubstantialEquivalenceAssessment | |
|---|---|---|---|
| 510(K) Number | K212500 | K060096 | N/A |
| Manufacture | LivsMed, Inc. | Applied MedicalResources Corp. | N/A |
| Device Name | ArtiSential Trocar | Modular Trocar System | N/A |
| Clearance Date | N/A | 01-24-2006 | N/A |
| Classification /Regulation | Class 2 / 876.1500 | Class 2 / 876.1500 | Same |
| Product Code | GCJ | GCJ | Same |
| Intended for | Prescription Use | Prescription Use | Same |
| Indications forUse | ArtiSential Trocar has anapplication in general,abdominal, thoracic, andgynecologic minimallyinvasive procedures toestablish a path of entry forendoscopic instruments. | The Applied MedicalModular Trocar Systemis a sterile single usedevice, or may be usedwith a reusable stainlesssteel or reusableDuraGold® cannula andis intended for use inconjunction withApplied's currentlymarketed trocarproducts to establish apath of entry forendoscopic instrumentsfor use during general,abdominal, | Same |
| thoracic minimallyinvasive procedures orto gain access throughtissue planes and/orpotential spaces forendoscopic instruments.If utilizing the AppliedMedical OpticalSeparator Obturatorwith the Modular TrocarSystem it may be usedwith or withoutvisualization for primaryand secondaryinsertions. | |||
| Description | ArtiSential Trocar is foruse during endoscopicminimally invasiveprocedures or to gainaccess potential spaces forendoscopic instruments.This device is a sterile,single-use instrumentsconsisting of a main body,cannula, obturator. Anoptical element, whichwhen used with anendoscope, providesvisibility of individualtissue layers duringinsertion.And a funnel serves as aninstrument insertion guideand aids in the insertion ofa passive multi-jointsurgical instrument into thecannula. | The Modular TrocarSystem is a sterile singleuse device, intended foruse in conjunction withApplied's currentlymarketed Trocar products.A standard trocar assemblyconsists of an obturator, aseal and a cannula system.The Modular TrocarSystem will be availablein sizes of 5mm, 8mm,11mm, 12mm and15mm diameter inlengths ranging from55mm to 150mm. | Similar: Thedescription ofthe proposedArtiSentialTrocar is assame as thepredicatedevices exceptfor the functionof the funnelpart, which is anoptional featurethat the userselects. Also,given thetechnologicalcharacteristicsof the proposedArtiSentialTrocar areidentical to thepredicateproducts.Designverification andvalidationtesting of theproposed Trocarhave providedreasonableassurance thatthe proposedArtiSentialTrocar areappropriate forthe proposedindications foruse and can beas safely andeffectively used |
| as predicatedevices. | |||
| Principles ofoperation | This product is a sterile,single-use productwhich is composed ofmain body, cannula,obturator that isgenerally used ininvasive surgery tocreate passageways forsurgery in the abdomen,gynecology, chest,access through tissues,or to make space forendoscopic instruments.The obturator has anoptical element appliedto visualize the tissuelayer during insertioninto the body, and afunnel serves as aninstrument insertionguide and aids in theinsertion of a passivemulti-joint surgicalinstrument into thecannula. | This product consists ofa sleeve and anobturator that aregenerally used inminimally invasivesurgery to create apassageway for surgeryin the abdomen,gynecology, chest,access through tissue, orto make space forendoscopic instruments.It is a sterile disposableproduct.The optical type uses aseparate obturator withoptical elements applied tovisualize the tissue layerduring insertion, and theshielded bladed typeincludes a blade. | Similar: Theoperationprinciple of theproposedArtiSentialTrocar is assame as thepredicatedevices exceptfor the functionof the funnelpart, which is anoptional featurethat the userselects. Also,given thetechnologicalcharacteristicsof the proposedArtiSentialTrocar areidentical to thepredicateproducts.Designverification andvalidationtesting of theproposed Trocarhave providedreasonableassurance thatthe proposedArtiSentialTrocar areappropriate forthe proposedindications foruse and can beas safely andeffectively usedas predicatedevices. |
| Physicaldimensions anddesign(diameter, lengthof Cannula) | -Diameter: 8mm-Length: 100mm | -Diameter: 8mm-Length: 100mm | Same |
| Raw Materials | Similar | ||
| -Cannula: Polycarbonate (PC) | -Cannula: Copolyester | : Raw materials | |
| -Obturator: Polycarbonate (PC) | -Obturator: Polycarbonate (PC) | of the proposed | |
| ArtiSential | |||
| Trocar are same | |||
| as the predicate | |||
| device(K060096 | |||
| ), except | |||
| Copolyester of | |||
| the predicate | |||
| device's raw | |||
| material. All | |||
| patient | |||
| contacting | |||
| materials of | |||
| proposed | |||
| ArtiSential | |||
| Trocar have | |||
| been tested per | |||
| the same | |||
| standards of | |||
| ISO 10993-1. | |||
| Given the | |||
| favorable | |||
| biocompatibility | |||
| test results, the | |||
| difference | |||
| between raw | |||
| material of | |||
| proposed device | |||
| and predicate | |||
| device does not | |||
| raise different | |||
| questions in | |||
| safety and | |||
| effectiveness | |||
| Sterilization | EO Sterilization | Radiation | Although it is |
| different from | |||
| the sterilization | |||
| method of the | |||
| predicate | |||
| device, the | |||
| effectiveness of | |||
| our sterilization | |||
| method was | |||
| verified through | |||
| the sterilization | |||
| validation test | |||
| and the | |||
| accelerated | |||
| aging test |
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6. Performance Data
6.1 Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity -
- -Sensitization
- -Intracutaneous reactivity
- Acute systemic toxicity -
- Pyrogenicity -
6.2 Sterilization
ArtiSential Trocar is provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.
6.3 Shelf life
The proposed expiration date is 3 years from the manufacturing date. Following tests were conducted zero time point and 3 years accelerated aging point and the device had passed all tests as below.
-
- Packaging and sterility test
- . Packaging integrity test
- . Sealing strength test of packaging (per ASTM F 88/F88M-15)
- Dye penetration test (per ASTM F1929)
- . Sterility test (per ISO 11737- 2)
- Performance test 2)
- Appearance
- . Dimension
- Leak test .
- Tensile Strength
6.4 Performance test
- 6.4.1 Bench test
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The testing was conducted side-by-side with the predicate device as following and had passed all performed tests.
- Appearance
- . Dimension
- Leak test .
- . Tensile Strength
- . the ability to 1) maintain pneumoperitoneum (with and without instruments inserted) and 2) manipulate instruments for laparoscopic surgery.
6.4.2 Animal testing
The device was conducted side-by-side in vivo (micro pig, M-type) testing with the predicate device as following. The device had passed all performed tests.
- . Tissue insertion and retention forces
- . Intra-abdominal pressure
- . Obturator integrity after insertion
Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has the same or similar performance characteristics to the predicate device.
7. Conclusions
Overall, the comparison carried out covers physical dimension, design, performance and the entire indication for use of the device under evaluation. The subject device which is the ArtiSential Trocar is considerably as same as the predicate device in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate device. Results of validation and verification activities in design control that include testing/certification to designated standards and performance testing of the devices has demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device for the requested intended use.
In conclusion, no different questions in safety and effectiveness assessment are being raised compared to the predicate device.
§ 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.