(394 days)
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke
The provided text describes a 510(k) premarket notification for the AFS Medical Sterile Single-Use Access Port System. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility testing, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories in your prompt are not applicable to this submission.
However, I can extract the relevant information regarding acceptance criteria and testing results:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| Leak, Instrument Insertion/Withdrawal, and Insufflation | Insertion, withdrawal, leak, and insufflation performance must be acceptable and equivalent to the reference device. Insufflation port performance must be confirmed at 20 LPM. | Insertion, withdrawal, leak, and insufflation performance were acceptable; Pass. |
| Smoke Evacuation | Acceptable smoke evacuation performance under simulated use conditions. | Smoke evacuation performance was acceptable; Pass. |
| Power Line Connection Force | Force to disconnect power line from the controller unit must be >30N. | Power line connection force was >30 N; Pass. |
| LED Intensity and Holding Time | Illumination must be >30,000 lux and maintain holding time for at least one hour. | Illumination and holding time met the acceptance criteria; Pass. |
| Electrical Safety Testing | Must meet relevant clauses of IEC 60601-1. | All requirements were met; Pass. |
| Electromagnetic Compatibility | Must meet relevant clauses of IEC 60601-1-2. | All requirements were met; Pass. |
| Biocompatibility Testing | ||
| Cytotoxicity | Noncytotoxic according to predetermined acceptance criteria. | Noncytotoxic according to the predetermined acceptance criteria; Pass. |
| Intracutaneous Irritation | Test requirements for intracutaneous reactivity must be met according to predetermined acceptance criteria. | Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria; Pass. |
| Sensitization | Must not elicit a sensitization response according to predetermined acceptance criteria. | Did not elicit a sensitization response according to the predetermined acceptance criteria; Pass. |
| Clinical Testing (Qualitative) | No adverse events related to the device and assessed performance of all key attributes as acceptable. | No adverse events related to the device and assessed performance of all key attributes as acceptable. |
2. Sample size used for the test set and the data provenance
- Non-Clinical Performance Tests: Sample sizes are not explicitly stated for individual tests. The data provenance is internal testing performed by the manufacturer, likely in a laboratory setting.
- Clinical Testing: "Real-world data was collected from two independent clinical sites in Austria." The number of procedures or patients is not specified. This is prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Non-Clinical Performance Tests: Not applicable, as these are objective engineering and material tests, not reliant on expert interpretation for "ground truth."
- Clinical Testing: The text mentions "multiple clinicians reported no adverse events related to the device and assessed performance of all key attributes as acceptable." The exact number or qualifications of these clinicians are not specified beyond their role in performing procedures at clinical sites.
4. Adjudication method for the test set
- Non-Clinical Performance Tests: Not applicable as these are objective tests.
- Clinical Testing: Not specified, beyond the general statement that "multiple clinicians" assessed performance. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This submission is for a surgical access port system, not a diagnostic AI device that would utilize such a study design.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm or an AI-powered system designed for standalone performance.
7. The type of ground truth used
- Non-Clinical Performance Tests: Objective measurements against engineering and materials standards (e.g., force measurements, light intensity, leakage rates, compliance with IEC standards).
- Biocompatibility Testing: Laboratory results from standardized biological tests (ISO 10993 series).
- Clinical Testing: Clinician assessment of device performance and adverse event reporting based on real-world use during surgical procedures.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AFS Medical Co. Ltd. % Michele Lucey Regulatory Affairs Advisor Lakeshore Medical Device Consulting LLC 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K202688
Trade/Device Name: AFS Medical Sterile Single-Use Access Port System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OTJ, GCJ Dated: September 3, 2021 Received: September 13, 2021
Dear Michele Lucey:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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 Trumbore Acting 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
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SECTION 5
FDA FORM 3881 INDICATIONS FOR USE
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Indications for Use
510(k) Number (if known)
Device Name
AFS Medical Sterile Single-Use Access Port System
Indications for Use (Describe)
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site
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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K202688 510(K) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | AFS Medical Co. Ltd. |
|---|---|
| Address: | Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro Gimpo-Si |
| Gyeonggi-do 10048, Republic of Korea | |
| Telephone: | 82-10-5358-2661 |
| Fax: | 82-2-6958-8895 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 7, 2021 |
| Device Trade Name: | AFS Medical Sterile Single-Use Access Port System |
| Classification: | 2 |
| Classification Name: | Single Incision Access System |
| Common or Usual Name: | Single Incision Access System |
| Product Code(s):Subsequent Product Code | OTJGCJ |
| Regulation Number(s): | 878.1500 |
Primary Predicate Devices: GelPort Single Incision Access System (K090275),
| Secondary Predicate: | GelPort Laparoscopic Hand Access Device (K014047 |
|---|---|
| Reference Device: | SILS™ Port, Model SILSPTT112A, K103253 |
| Reference Device: | OBP ONETRAC LX Illuminated Retractor |
| Reference Device: | GelPoint Advanced Access Platform (K110792) |
Intended Use:
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. Examples of procedures where the device may be used include colorectal, and general surgery to access the surgical site.
Device Description
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The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke
Summary of Non-Clinical Testing:
The following performance tests were conducted. Testing focused on functional performance requirements consistent with the intended use of the device. Comparative testing to a reference device was conducted where appropriate.
| Non-Clinical Performance Test Summary | |||
|---|---|---|---|
| Study Name | Description | Reference Standard | Results |
| Leak, InstrumentInsertion/Withdrawal, andInsufflation | Tests for leakage duringinstrument manipulation,measures insertion an withdrawalforces, results must be equivalentwhen compared to the referencedevice. Test also confirmsinsufflation port performance at20 LPM. | NA | Insertion,withdrawal, leak,and insufflationperformance wereacceptable, Pass |
| Smoke evacuation | Assessed smoke evacuationperformance under simulated useconditions | NA | Smoke evacuationperformance wasacceptable, Pass |
| Power line connectionforce | Tests the security of power lineconnection to the controller unit.Force to disconnect must be >30N | NA | Power lineconnection forcewas > 30 N, Pass |
| LED Intensity andHolding Time | Intensity is measured by anilluminometer in a dark room andmust be >30 000 lux illuminationmust maintain a holding time forat least one hour | NA | Illumination andholding time metthe acceptancecriteria, Pass |
| Electrical Safety Testing | Must meet relevant clauses | IEC 60601-1 | All requirementswere met, Pass |
| ElectromagneticCompatibility | Must meet relevant clauses | IEC 60601-1-2 | All requirementswere met, Pass |
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Biocompatibility Testing Summary
Categorized as Externally Communicating Device, Limited Contact (≤ 24 hours), per ISO 10993-1, the following testing was conducted:
| Test Name | Test Method | Results |
|---|---|---|
| Cytotoxicity | Tested in accordance with ISO 10993-5, BiologicalEvaluation of Medical Devices – Part 5: Tests for invitro toxicity, Neutral Red Uptake Method | PassNoncytotoxic according to thepredetermined acceptance criteria |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices – Part 10: Tests forIrritation and Skin Sensitization | PassTest requirements forintracutaneous reactivity were metaccording to the predeterminedacceptance criteria |
| Sensitization | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices – Part 10 Tests forIrritation and Skin Sensitization, KligmanMaximization Test | Passdid not elicit a sensitizationresponse according to thepredetermined acceptance criteria |
Clinical Testing
Real-world data was collected from two independent clinical sites in Austria. Results from procedures performed by multiple clinicians reported no adverse events related to the device and assessed performance of all key attributes as acceptable.
Predicate Device Comparison
The following table provides a comparison of the key characteristics of the AFS Medical Sterile Single-Use Access Port System to the predicate devices.
| Comparison chart | ||||
|---|---|---|---|---|
| Feature | Subject Device | PrimaryPredicateDevice | SecondaryPredicate Device | Comparison |
| AFS MedicalSterile Single-Use Access PortSystem | AppliedMedicalGelPortSingle IncisionAccess System | Applied MedicalGelPortSingle IncisionAccess System | Pending | K090275 |
| RegulatoryClearance/ApprovalReference | FDAClassification | Class II | Class II | K014047 |
| Class II | Product Code(s) | OTJ | GCJ | OTJ |
| Class II | RegulationNumber | 876.1500 | 876.1500 | 876.1500 |
| GCJ | AnatomicalLocation | Abdomen | Abdomen | Abdomen |
| 876.1500 | Insertion | Through anincision | Through anincision | Through anincision |
| Abdomen | Through an incision | |||
| Comparison chart | ||||
| Feature | Subject Device | PrimaryPredicateDevice | SecondaryPredicate Device | Comparison |
| Anchoring | AFS MedicalSterile Single-Use Access PortSystem | AppliedMedicalGelPortSingle IncisionAccess System | Applied MedicalGelPortSingle IncisionAccess System | Secured to the patientvis a sleeve typewound protector |
| Mechanism ofAction | Secured to thepatient vis asleeve typewound protector | Secured to thepatient vis asleeve typewound protector | Secured to thepatient vis a sleevetype woundprotector | Secured to the patientvis a sleeve typewound protector |
| Retractor diameter | Serves as awound retractorand access portfor surgicalinstruments | Serves as awound retractorand access portfor surgicalinstruments | Serves as a woundretractor andaccess port forsurgicalinstruments | Serves as a woundretractor and accessport for surgicalinstruments |
| AccessMechanism | 45-130mm | Multiplediameters (40-120mm) | Multiple diameters(40-120mm) | Similar, difference inthe overall design andprincipal of operationare minor and do notraise questions ofsafety or efficacy asthe general principlefor use is the same |
| Port sizes | Integrated portsof various sizesand number | Trocars areinserted directlythrough the gelcap to create aport tointroduceinstruments | Trocars areinserted directlythrough the gel capto create a port tointroduceinstruments | Similar, difference inthe overall design andprincipal of operationare minor, access isachieved in the samemanner and do notraise questions ofsafety or efficacy asthe general principlefor use is the same. |
| 5-15mm | NA, trocars areplaced throughgel cap | NA, trocars areplaced through gelcap | Difference does notaffect the mechanismof action, access isachieved in a similarfashion and does notraise questions ofsafety or efficacy | |
| Comparison chart | ||||
| Subject Device | PrimaryPredicateDevice | SecondaryPredicate Device | ||
| Feature | AFS MedicalSterile Single-Use Access PortSystem | AppliedMedicalGelPortSingle IncisionAccess System | Applied MedicalGelPortSingle IncisionAccess System | Comparison |
| Port Number | 1-4 | NA, trocars areplaced throughgel cap | NA, trocars areplaced through gelcap | Difference does notaffect the mechanismof action, access isachieved in a similarfashion and do notraise questions ofsafety or efficacy. |
| Requires Trocar | No, includesports forinstrumentinsertion | Yes | Yes | Difference does notaffect the mechanismof action, access isachieved in a similarfashion, however theAFS devices eliminatethe need for a sharptrocar blade to beinserted. Differencedoes not raisequestions of safety orefficacy. |
| Incision size | 1.6-9 cm | 1.5-9 cm | 1.5-9 cm | Same |
| Incision retractionangle | 360° | 360° | 360° | Same |
| Hand Access | Yes, by capremoval | Yes, by capremoval | Yes, by insertionthrough the slit inthe Gel Cap | Same |
| Insufflation/smokeevacuation ports | Yes, two ports | No | No | Performancecomparison toreference deviceconfirmed equivalentperformance. Thisdifference does notraise questions ofsafety or efficacy |
| Battery poweredintegratedillumination | Yes, on somemodels | No | No | Illumination is adjunctand is not areplacement for |
| Comparison chart | ||||
| Feature | Subject Device | PrimaryPredicateDevice | SecondaryPredicate Device | Comparison |
| AFS MedicalSterile Single-Use Access PortSystem | AppliedMedicalGelPortSingle IncisionAccess System | Applied MedicalGelPortSingle IncisionAccess System | standard illumination(endoscope),difference does notaffect the mechanismof action of the device.This feature is foundin other surgicaldevice accessories(illuminated retractorswith LED light Sourceand SmokeEvacuation, batteryoperated (Class I),OBP ONETRAC LX).Difference does notraise questions ofsafety or efficacy. | |
| Materials – SterileSingle Use SystemComponents | Various polymersand stainlesssteel | Variouspolymers,stainless steel,and lubricant | Various polymers,stainless steel, andlubricant | Same |
| InstrumentCapability | Endoscopicinstrumentsranging in sizefrom 5-25mm | Endoscopicinstrument sizenot specified | Endoscopicinstrument size notspecified | Same, thoughpredicate isnonspecific |
| InstrumentArticulation | Yes, by means offlexible ports | Yes, by meansof a flexiblemembrane | Yes, by means of aflexible membrane | Same |
| Cap to sealingring seal indicator | Blue lights whenlit indicate thecap is sealed tothe sealing ring | No | No | Difference does notaffect the mechanismof action of the deviceand does not raisequestions of safety orefficacy |
| Sealing ringrotation | 360° | Fixed | Fixed | Difference does notaffect the mechanism |
| Comparison chart | ||||
| Feature | Subject Device | PrimaryPredicateDevice | SecondaryPredicate Device | Comparison |
| AFS MedicalSterile Single-Use Access PortSystem | AppliedMedicalGelPortSingle IncisionAccess System | Applied MedicalGelPortSingle IncisionAccess System | of action of the deviceand does not raisequestions of safety orefficacy. | |
| Insufflation ports | Yes | No | No | Insufflation for theGelPort is through thecap via the trocar.Difference does notaffect the mechanismof action of the deviceand does not raisequestions of safety orefficacy. |
| Maintainsinsufflation whilearticulatinginstruments | Yes | Yes | Yes | Same |
| Convert to openprocedure | Yes, by removalof the Port Head,retractor remains | Yes, by removalof the Gel Cap,retractorremains | Yes, by removal ofthe Gel Cap,retractor remains | Same |
| How Supplied | Sterile, single use | Sterile, singleuse | Sterile, single use | Same |
| SterilizationMethod | EtO | Unknown | Unknown | This difference doesnot affect thesterilization status ofthe device |
| SterilityAssurance Level | 10-6 | 10-6 | 10-6 | Same |
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Conclusion:
Based on a review of bench top assessments, comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility the subject device is as safe, as effective, and performs as well as or better than the legally marketed 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.