(394 days)
No
The device description and performance studies focus on mechanical and electrical functionalities (access, illumination, insufflation, smoke evacuation, electrical safety, biocompatibility) and manual operation. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as an "Access Port System for surgery" designed to "access the peritoneal cavity during laparoscopic surgery." Its function is to provide access to a surgical site, with features like illumination and insufflation. It does not actively treat a disease or condition.
No
Explanation: The device is described as a "Sterile Single-Use Access Port System for surgery" designed to provide access to the peritoneal cavity during laparoscopic surgery. Its functions include providing illumination, insufflation ports, and facilitating instrument insertion, rather than diagnosing a medical condition.
No
The device description clearly outlines physical components such as ports, LED lighting, insufflation ports, retractor, receiving ring, and smart tubing. The performance studies also include testing of physical attributes like leak, insertion/withdrawal, electrical safety, and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "accessing the peritoneal cavity during laparoscopic surgery." This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device used for surgical access, including features like ports, illumination, and insufflation. These are all related to surgical intervention, not in vitro analysis.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for surgical access.
N/A
Intended Use / Indications for 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, urological, and general surgery to access the surgical site
Product codes (comma separated list FDA assigned to the subject device)
OTJ, GCJ
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
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 Testing:
- Leak, Instrument Insertion/Withdrawal, and Insufflation: Tests for leakage during instrument manipulation, measures insertion and withdrawal forces, and confirms insufflation port performance at 20 LPM. Results: Insertion, withdrawal, leak, and insufflation performance were acceptable, Pass.
- Smoke evacuation: Assessed smoke evacuation performance under simulated use conditions. Results: Smoke evacuation performance was acceptable, Pass.
- Power line connection force: Tests the security of power line connection to the controller unit. Force to disconnect must be >30N. Results: Power line connection force was > 30 N, Pass.
- LED Intensity and Holding Time: Intensity is measured by an illuminometer in a dark room and must be >30 000 lux illumination must maintain a holding time for at least one hour. Results: Illumination and holding time met the acceptance criteria, Pass.
- Electrical Safety Testing: Must meet relevant clauses per IEC 60601-1. Results: All requirements were met, Pass.
- Electromagnetic Compatibility: Must meet relevant clauses per IEC 60601-1-2. Results: All requirements were met, Pass.
Biocompatibility Testing:
- Cytotoxicity: Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices – Part 5: Tests for in vitro toxicity, Neutral Red Uptake Method. Results: Pass, Noncytotoxic according to the predetermined acceptance criteria.
- Intracutaneous Irritation: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization. Results: Pass, Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria.
- Sensitization: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices – Part 10 Tests for Irritation and Skin Sensitization, Kligman Maximization Test. Results: Pass, did not elicit a sensitization response according to the predetermined 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K103253, OBP ONETRAC LX Illuminated Retractor, K110792
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
SECTION 5
FDA FORM 3881 INDICATIONS FOR USE
3
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) | □ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 | OTJ |
| GCJ | |
| 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
5
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, Instrument | |||
| Insertion/Withdrawal, and | |||
| Insufflation | Tests for leakage during | ||
| instrument manipulation, | |||
| measures insertion an withdrawal | |||
| forces, results must be equivalent | |||
| when compared to the reference | |||
| device. Test also confirms | |||
| insufflation port performance at | |||
| 20 LPM. | NA | Insertion, | |
| withdrawal, leak, | |||
| and insufflation | |||
| performance were | |||
| acceptable, Pass | |||
| Smoke evacuation | Assessed smoke evacuation | ||
| performance under simulated use | |||
| conditions | NA | Smoke evacuation | |
| performance was | |||
| acceptable, Pass | |||
| Power line connection | |||
| force | Tests the security of power line | ||
| connection to the controller unit. | |||
| Force to disconnect must be >30N | NA | Power line | |
| connection force | |||
| was > 30 N, Pass | |||
| LED Intensity and | |||
| Holding Time | Intensity is measured by an | ||
| illuminometer in a dark room and | |||
| must be >30 000 lux illumination | |||
| must maintain a holding time for | |||
| at least one hour | NA | Illumination and | |
| holding time met | |||
| the acceptance | |||
| criteria, Pass | |||
| Electrical Safety Testing | Must meet relevant clauses | IEC 60601-1 | All requirements |
| were met, Pass | |||
| Electromagnetic | |||
| Compatibility | Must meet relevant clauses | IEC 60601-1-2 | All requirements |
| were met, Pass |
6
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, Biological | |
| Evaluation of Medical Devices – Part 5: Tests for in | ||
| vitro toxicity, Neutral Red Uptake Method | Pass | |
| Noncytotoxic according to the | ||
| predetermined acceptance criteria | ||
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices – Part 10: Tests for | ||
| Irritation and Skin Sensitization | Pass | |
| Test requirements for | ||
| intracutaneous reactivity were met | ||
| according to the predetermined | ||
| acceptance criteria | ||
| Sensitization | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices – Part 10 Tests for | ||
| Irritation and Skin Sensitization, Kligman | ||
| Maximization Test | Pass | |
| did not elicit a sensitization | ||
| response according to the | ||
| predetermined 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 | Primary | ||
| Predicate | ||||
| Device | Secondary | |||
| Predicate Device | Comparison | |||
| AFS Medical | ||||
| Sterile Single- | ||||
| Use Access Port | ||||
| System | Applied | |||
| Medical | ||||
| GelPort | ||||
| Single Incision | ||||
| Access System | Applied Medical | |||
| GelPort | ||||
| Single Incision | ||||
| Access System | Pending | K090275 | ||
| Regulatory | ||||
| Clearance/ | ||||
| Approval | ||||
| Reference | FDA | |||
| Classification | Class II | Class II | K014047 | |
| Class II | Product Code(s) | OTJ | GCJ | OTJ |
| Class II | Regulation | |||
| Number | 876.1500 | 876.1500 | 876.1500 | |
| GCJ | Anatomical | |||
| Location | Abdomen | Abdomen | Abdomen | |
| 876.1500 | Insertion | Through an | ||
| incision | Through an | |||
| incision | Through an | |||
| incision | ||||
| Abdomen | Through an incision | |||
| Comparison chart | ||||
| Feature | Subject Device | Primary | ||
| Predicate | ||||
| Device | Secondary | |||
| Predicate Device | Comparison | |||
| Anchoring | AFS Medical | |||
| Sterile Single- | ||||
| Use Access Port | ||||
| System | Applied | |||
| Medical | ||||
| GelPort | ||||
| Single Incision | ||||
| Access System | Applied Medical | |||
| GelPort | ||||
| Single Incision | ||||
| Access System | Secured to the patient | |||
| vis a sleeve type | ||||
| wound protector | ||||
| Mechanism of | ||||
| Action | Secured to the | |||
| patient vis a | ||||
| sleeve type | ||||
| wound protector | Secured to the | |||
| patient vis a | ||||
| sleeve type | ||||
| wound protector | Secured to the | |||
| patient vis a sleeve | ||||
| type wound | ||||
| protector | Secured to the patient | |||
| vis a sleeve type | ||||
| wound protector | ||||
| Retractor diameter | Serves as a | |||
| wound retractor | ||||
| and access port | ||||
| for surgical | ||||
| instruments | Serves as a | |||
| wound retractor | ||||
| and access port | ||||
| for surgical | ||||
| instruments | Serves as a wound | |||
| retractor and | ||||
| access port for | ||||
| surgical | ||||
| instruments | Serves as a wound | |||
| retractor and access | ||||
| port for surgical | ||||
| instruments | ||||
| Access | ||||
| Mechanism | 45-130mm | Multiple | ||
| diameters (40- | ||||
| 120mm) | Multiple diameters | |||
| (40-120mm) | Similar, difference in | |||
| the overall design and | ||||
| principal of operation | ||||
| are minor and do not | ||||
| raise questions of | ||||
| safety or efficacy as | ||||
| the general principle | ||||
| for use is the same | ||||
| Port sizes | Integrated ports | |||
| of various sizes | ||||
| and number | Trocars are | |||
| inserted directly | ||||
| through the gel | ||||
| cap to create a | ||||
| port to | ||||
| introduce | ||||
| instruments | Trocars are | |||
| inserted directly | ||||
| through the gel cap | ||||
| to create a port to | ||||
| introduce | ||||
| instruments | Similar, difference in | |||
| the overall design and | ||||
| principal of operation | ||||
| are minor, access is | ||||
| achieved in the same | ||||
| manner and do not | ||||
| raise questions of | ||||
| safety or efficacy as | ||||
| the general principle | ||||
| for use is the same. | ||||
| 5-15mm | NA, trocars are | |||
| placed through | ||||
| gel cap | NA, trocars are | |||
| placed through gel | ||||
| cap | Difference does not | |||
| affect the mechanism | ||||
| of action, access is | ||||
| achieved in a similar | ||||
| fashion and does not | ||||
| raise questions of | ||||
| safety or efficacy | ||||
| Comparison chart | ||||
| Subject Device | Primary | |||
| Predicate | ||||
| Device | Secondary | |||
| Predicate Device | ||||
| Feature | AFS Medical | |||
| Sterile Single- | ||||
| Use Access Port | ||||
| System | Applied | |||
| Medical | ||||
| GelPort | ||||
| Single Incision | ||||
| Access System | Applied Medical | |||
| GelPort | ||||
| Single Incision | ||||
| Access System | Comparison | |||
| Port Number | 1-4 | NA, trocars are | ||
| placed through | ||||
| gel cap | NA, trocars are | |||
| placed through gel | ||||
| cap | Difference does not | |||
| affect the mechanism | ||||
| of action, access is | ||||
| achieved in a similar | ||||
| fashion and do not | ||||
| raise questions of | ||||
| safety or efficacy. | ||||
| Requires Trocar | No, includes | |||
| ports for | ||||
| instrument | ||||
| insertion | Yes | Yes | Difference does not | |
| affect the mechanism | ||||
| of action, access is | ||||
| achieved in a similar | ||||
| fashion, however the | ||||
| AFS devices eliminate | ||||
| the need for a sharp | ||||
| trocar blade to be | ||||
| inserted. Difference | ||||
| does not raise | ||||
| questions of safety or | ||||
| efficacy. | ||||
| Incision size | 1.6-9 cm | 1.5-9 cm | 1.5-9 cm | Same |
| Incision retraction | ||||
| angle | 360° | 360° | 360° | Same |
| Hand Access | Yes, by cap | |||
| removal | Yes, by cap | |||
| removal | Yes, by insertion | |||
| through the slit in | ||||
| the Gel Cap | Same | |||
| Insufflation/smoke | ||||
| evacuation ports | Yes, two ports | No | No | Performance |
| comparison to | ||||
| reference device | ||||
| confirmed equivalent | ||||
| performance. This | ||||
| difference does not | ||||
| raise questions of | ||||
| safety or efficacy | ||||
| Battery powered | ||||
| integrated | ||||
| illumination | Yes, on some | |||
| models | No | No | Illumination is adjunct | |
| and is not a | ||||
| replacement for | ||||
| Comparison chart | ||||
| Feature | Subject Device | Primary | ||
| Predicate | ||||
| Device | Secondary | |||
| Predicate Device | Comparison | |||
| AFS Medical | ||||
| Sterile Single- | ||||
| Use Access Port | ||||
| System | Applied | |||
| Medical | ||||
| GelPort | ||||
| Single Incision | ||||
| Access System | Applied Medical | |||
| GelPort | ||||
| Single Incision | ||||
| Access System | standard illumination | |||
| (endoscope), | ||||
| difference does not | ||||
| affect the mechanism | ||||
| of action of the device. | ||||
| This feature is found | ||||
| in other surgical | ||||
| device accessories | ||||
| (illuminated retractors | ||||
| with LED light Source | ||||
| and Smoke | ||||
| Evacuation, battery | ||||
| operated (Class I), | ||||
| OBP ONETRAC LX). | ||||
| Difference does not | ||||
| raise questions of | ||||
| safety or efficacy. | ||||
| Materials – Sterile | ||||
| Single Use System | ||||
| Components | Various polymers | |||
| and stainless | ||||
| steel | Various | |||
| polymers, | ||||
| stainless steel, | ||||
| and lubricant | Various polymers, | |||
| stainless steel, and | ||||
| lubricant | Same | |||
| Instrument | ||||
| Capability | Endoscopic | |||
| instruments | ||||
| ranging in size | ||||
| from 5-25mm | Endoscopic | |||
| instrument size | ||||
| not specified | Endoscopic | |||
| instrument size not | ||||
| specified | Same, though | |||
| predicate is | ||||
| nonspecific | ||||
| Instrument | ||||
| Articulation | Yes, by means of | |||
| flexible ports | Yes, by means | |||
| of a flexible | ||||
| membrane | Yes, by means of a | |||
| flexible membrane | Same | |||
| Cap to sealing | ||||
| ring seal indicator | Blue lights when | |||
| lit indicate the | ||||
| cap is sealed to | ||||
| the sealing ring | No | No | Difference does not | |
| affect the mechanism | ||||
| of action of the device | ||||
| and does not raise | ||||
| questions of safety or | ||||
| efficacy | ||||
| Sealing ring | ||||
| rotation | 360° | Fixed | Fixed | Difference does not |
| affect the mechanism | ||||
| Comparison chart | ||||
| Feature | Subject Device | Primary | ||
| Predicate | ||||
| Device | Secondary | |||
| Predicate Device | Comparison | |||
| AFS Medical | ||||
| Sterile Single- | ||||
| Use Access Port | ||||
| System | Applied | |||
| Medical | ||||
| GelPort | ||||
| Single Incision | ||||
| Access System | Applied Medical | |||
| GelPort | ||||
| Single Incision | ||||
| Access System | of action of the device | |||
| and does not raise | ||||
| questions of safety or | ||||
| efficacy. | ||||
| Insufflation ports | Yes | No | No | Insufflation for the |
| GelPort is through the | ||||
| cap via the trocar. | ||||
| Difference does not | ||||
| affect the mechanism | ||||
| of action of the device | ||||
| and does not raise | ||||
| questions of safety or | ||||
| efficacy. | ||||
| Maintains | ||||
| insufflation while | ||||
| articulating | ||||
| instruments | Yes | Yes | Yes | Same |
| Convert to open | ||||
| procedure | Yes, by removal | |||
| of the Port Head, | ||||
| retractor remains | Yes, by removal | |||
| of the Gel Cap, | ||||
| retractor | ||||
| remains | Yes, by removal of | |||
| the Gel Cap, | ||||
| retractor remains | Same | |||
| How Supplied | Sterile, single use | Sterile, single | ||
| use | Sterile, single use | Same | ||
| Sterilization | ||||
| Method | EtO | Unknown | Unknown | This difference does |
| not affect the | ||||
| sterilization status of | ||||
| the device | ||||
| Sterility | ||||
| Assurance Level | 10-6 | 10-6 | 10-6 | Same |
7
8
9
10
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.