(102 days)
This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.
The NexPort™ Trocar System 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 devices are available to accommodate 5mm and 10mm surgical instruments.
The 5mm NexPort™ Trocar System is consisted of:
- Obturator Shaft a)
- Cannula Cap b)
- Seal c)
- Duckbill Valve d)
- e) Cannula Body
- f) Luerlock Cap
- g) Obturator Tip Protector
- Cannula Tip Protector h)
The 10mm NexPort™ Trocar System is consisted of:
- a) Obturator Shaft
- Cannula Cap b)
- Seal c)
- Cannula Intermediate Plate d)
- Duckbill Valve e)
- f) Cannula Housing
- Stopcock g)
- Face Seal h)
- i) Cannula Sleeve
- Reducer j)
- Adaptor Cap k)
- I) Adaptor Top Body
- m) Adaptor Seal
- n) Adaptor Bottom Body
This is a 510(k) premarket notification for a medical device called the "NexPort™ Trocar System". This document does not describe a study that uses AI or machine learning. Therefore, most of the requested information regarding acceptance criteria and study design for AI/ML performance evaluation is not available in this document.
However, I can provide the available information related to the device's validation and comparison to predicate devices, as well as the non-clinical tests performed.
Current Device: NexPort™ Trocar System
Summary of Device Validation and Performance (based on provided text):
The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a standalone performance study with specific acceptance criteria that would typically be seen for an AI/ML device. The validation involves non-clinical tests and comparison to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it details that the device has undergone various non-clinical tests and has been found to conform to applicable medical device safety standards.
The relevant "performance" is implicitly demonstrated through:
- Identical Intended Use/Indications for Use as predicate devices.
- Identical Principles of Operation as predicate devices.
- Identical Application Sites as predicate devices.
- Identical Single Use nature and Operation Mode (Manually) as predicate devices.
- Identical Sterilization Assurance Level (SAL) ($<=10^{-6}$) as predicate devices.
- Biocompatibility: Confirmed to meet the same biocompatibility tests as predicate devices (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity).
- Mechanical Safety: Confirmed through non-clinical tests.
- Aging/Shelf-Life: Evaluated through accelerated and real-time aging tests.
- In Vivo Study (Porcine Model): Evaluated penetration force, fixation force, and tip integrity, found to conform to applicable medical device safety standards. (No specific numerical results or acceptance criteria are presented in this summary).
Therefore, a table summarizing acceptance criteria and performance would look like this based on the provided text:
| Acceptance Criteria Category | Reported Device Performance (Conformity) |
|---|---|
| Intended Use | Identical to predicate devices. |
| Principles of Operation | Identical to Disposable Endoscopic Trocar (K180208) predicate device. |
| Application Sites | Identical to predicate devices. (Abdominal, Thoracic, Gynecologic) |
| Single Use | Yes, identical to predicate devices. |
| Operation Mode | Manually, identical to predicate devices. |
| Sterilization Assurance Level (SAL) | $<=10^{-6}$, identical to predicate devices. |
| Method of Sterilization | Irradiation, same as predicate K180208. |
| Biocompatibility | Passed Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity; "Identical" to predicate devices in listed tests. |
| Mechanical Safety | Conform to applicable medical device safety standards (details not provided in summary, but indicated as part of Performance Testing and Safety Testing). |
| Shelf Life/Aging | Evaluated through accelerated and real-time aging tests; results indicate conformity to standards (no specific shelf life duration or test results provided in summary). |
| In Vivo Performance | Evaluated penetration force, fixation force, and tip integrity on a porcine model; found to conform to applicable medical device safety standards (no specific numerical results or acceptance criteria are provided in this summary, but the study was conducted). |
| Material Properties | Meets various ASTM and ISO standards for packaging components (ASTM F1140/F1140M-13, ASTM F88/F88M, ASTM F1929, ASTM F1980-16). (These are not "performance" of the primary device itself, but supporting components). |
| Risk Analysis | Performed as part of quality assurance. (No specific acceptance criteria or outcomes for risk analysis are provided in this summary, but it's a conformity statement). |
The following information is not applicable or not found in the provided text, as this document is for a traditional medical device (trocar system) and not an AI/ML driven device:
- Sample size used for the test set and the data provenance: Not applicable for an AI/ML test set. The in-vivo study mentioned a "porcine model" but did not specify sample size or provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests and the in-vivo study, the "ground truth" would be established by the physical and biological properties being measured and compared against established engineering and medical standards. For instance, biocompatibility is evaluated against ISO 10993 standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
{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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 20, 2023
MediConcepts Technology (Shenzhen) Company Limited Benjamin Chan Managing Director Building No. 37, Tongfu Industrial Estate, Dapeng New District Shenzhen City, Guangdong Province, China Shenzhen, Guangdong 518120 China
Re: K232042
Trade/Device Name: NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); NexPort™ Trocar System (TS221022); NexPort™ Trocar System (TS241020); NexPort™ Trocar System (TS241021); NexPort™ Trocar System (TS241022); NexPort™ Trocar System (TS331001); NexPort™ Trocar System (TS331002); NexPort™ Trocar System (TS331003); NexPort™ Trocar System (TS331004); NexPort™ Trocar System (TS332001); NexPort™ Trocar System (TS332002); NexPort™ Trocar System (TS332003); NexPort™ Trocar System (TS332004); NexPort™ Trocar System (TS332005); NexPort™ Trocar System (TS332006) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 17, 2023 Received: July 10, 2023
Dear Benjamin Chan:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination
{1}------------------------------------------------
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
{2}------------------------------------------------
assistance/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
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.20
14:20:41 -04'00'
Mark Trumbore, 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
{3}------------------------------------------------
Indications for Use
| Submission Number (if known) |
|---|
| K232042 |
| Device NameNexPort™ Trocar System (TS211001);NexPort™ Trocar System (TS211002);NexPort™ Trocar System (TS211003);NexPort™ Trocar System (TS211010);NexPort™ Trocar System (TS211011);NexPort™ Trocar System (TS211012);NexPort™ Trocar System (TS221001);NexPort™ Trocar System (TS221002);NexPort™ Trocar System (TS221003);NexPort™ Trocar System (TS221010);NexPort™ Trocar System (TS221011);NexPort™ Trocar System (TS221012);NexPort™ Trocar System (TS221020);NexPort™ Trocar System (TS221021);NexPort™ Trocar System (TS221022);NexPort™ Trocar System (TS241020);NexPort™ Trocar System (TS241021);NexPort™ Trocar System (TS241022);NexPort™ Trocar System (TS331001);NexPort™ Trocar System (TS331002);NexPort™ Trocar System (TS331003);NexPort™ Trocar System (TS331004);NexPort™ Trocar System (TS332001);NexPort™ Trocar System (TS332002);NexPort™ Trocar System (TS332003);NexPort™ Trocar System (TS332004);NexPort™ Trocar System (TS332005);NexPort™ Trocar System (TS332006)Indications for Use (Describe) |
This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.
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)
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-leaf clover design in blue and green. Below the clover is the text "MediConcepts" in a bold, sans-serif font, with the word "Group" appearing in a smaller font size underneath.
510(k) Summary
NexPort™ Trocar System
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features three interlocking shapes in blue and green, resembling a stylized clover or trefoil. Below the symbol, the text "MediConcepts Group" is written in a sans-serif font, with "MediConcepts" in a larger, bolder font and "Group" in a smaller font size.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| 1. Date: | July 8, 2023 |
|---|---|
| 2. Submitter: | MediConcepts Technology (Shenzhen) Company LimitedBuilding No. 37, Tongfu Industrial Estate, Dapeng NewDistrict, Shenzhen City, Guangdong Province, 518120, P.R.China |
| Contact person: | Nick XuRegulatory AffairsMediConcepts Technology (Shenzhen) Company LimitedBuilding No. 37, Tongfu Industrial Estate, Dapeng NewDistrict, Shenzhen City, Guangdong Province, 518120, P.R.ChinaTelephone: +86 13338102750Email: nick.xu@mediconcepts.com.hk |
-
- Device Name: NexPort™ Trocar System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| GCJ | Class II | 21 CFR Part 876.1500Laparoscope, General & Plastic Surgery | Endoscope &accessories |
4. Predicate Devices:
| Predicate Device 510 (k)number | Predicate Device name |
|---|---|
| K201641 | Disposable Laparoscope Trocar |
| K180208 | Disposable Endoscopic Trocar |
5. Device Description:
The NexPort™ Trocar System 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 devices are available to accommodate 5mm and 10mm surgical instruments.
The 5mm NexPort™ Trocar System is consisted of:
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features three overlapping shapes in the colors blue and green. The shapes are arranged in a circular pattern. Below the shapes, the text "MediConcepts Group" is written in a sans-serif font, with "MediConcepts" in a slightly larger and bolder font than "Group".
Image /page/6/Picture/2 description: This image shows an exploded view of a device with several labeled parts. Part a) is a long, thin tube with a wider section in the middle and a pointed end. Parts b), c), d), and e) are components that appear to fit together, forming a larger part of the device, while part f) is a separate, cylindrical piece with a handle. Finally, parts g) and h) are small, cylindrical pieces that seem to attach to the ends of part a).
- Obturator Shaft a)
- Cannula Cap b)
- Seal c)
- Duckbill Valve d)
- e) Cannula Body
- f) Luerlock Cap
- g) Obturator Tip Protector
- Cannula Tip Protector h)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a three-leaf clover design in blue and green. Below the clover is the text "MediConcepts Group" in a sans-serif font, with "MediConcepts" in a larger, bolder font than "Group."
Image /page/7/Figure/2 description: This image shows an exploded view of a device with several components labeled with letters. On the left, component 'a' is a long, thin tool with a rounded top. In the center, components 'b' through 'i' are arranged in a vertical stack, suggesting how they fit together, while on the right, components 'j' through 'n' are similarly arranged, showing another set of parts and their assembly.
The 10mm NexPort™ Trocar System is consisted of:
- a) Obturator Shaft
- Cannula Cap b)
- Seal c)
- Cannula Intermediate Plate d)
- Duckbill Valve e)
- f) Cannula Housing
- Stopcock g)
- Face Seal h)
- i) Cannula Sleeve
- Reducer j)
- Adaptor Cap k)
- I) Adaptor Top Body
- m) Adaptor Seal
- n) Adaptor Bottom Body
| Table 5.1 the differences between these models | |
|---|---|
| ------------------------------------------------ | -- |
| Diameter | 5mm | 10mm |
|---|---|---|
| Length | 65mm70mm95mm | 105mm |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-leaf clover design in blue and green. Below the clover is the text "MediConcepts" in a bold, sans-serif font, with the word "Group" appearing in a smaller font size underneath.
| Cannula Type | Microgroove CannulaRibbed Cannula | Microgroove Cannula |
|---|---|---|
| Pack | Single PackDual Pack | Single Pack |
| Obturator | MicroFlat Obturator | MicroFlat ObturatorBlunt ObturatorDilating Obturator |
| Transparency | TransparencyNon-transparency | TransparencyNon-transparency |
| Adaptor | N/A | Standard AdaptorSlimline Adaptor |
-
- Intended Use/Indications for Use:
The NexPort Trocar System is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or other minimally invasive procedures to establish a path of entry for minimally invasive instruments.
- Intended Use/Indications for Use:
-
- Technology:
The NexPort Trocar System employs the same fundamental scientific technology as its predicate devices.
- Technology:
-
- Determination of Substantial Equivalence:
Comparison to Predicate Devices:
- Determination of Substantial Equivalence:
Below table is the summary comparison of features of the NexPort™ Trocar System and the predicate devices.
| Feature | Proposed Device:NexPort™ Trocar System | Predicate Device:Disposable LaparoscopeTrocar (K201641) | Predicate Device:Disposable EndoscopicTrocar (K180208) | Discussion ofDifferences |
|---|---|---|---|---|
| Product Code | GCJ | GCJ | GCJ | Identical |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Feature | Proposed Device:NexPort™ Trocar System | Predicate Device:Disposable LaparoscopeTrocar (K201641) | Predicate Device:Disposable EndoscopicTrocar (K180208) | Discussion ofDifferences |
| Intended/Indicationsfor use | NexPort™ Trocar System is asterile, single-use deviceand indicated for use ingeneral, thoracic,gynecologic, or minimallyinvasive procedures toestablish a path of entry forminimally invasiveinstruments. | The Disposable LaparoscopeTrocar has applications inabdominal, thoracic, andgynecologic minimallyinvasive surgical procedures toestablish a path of entry forendoscopic instruments. Thetrocar may be used with orwithout visualization forprimary and secondaryinsertions. | The DisposableEndoscopic Trocar hasapplications in abdominal,thoracic, and gynecologicminimally invasivesurgical procedures toestablish a path of entry forendoscopic instruments.The trocar may be usedwith or withoutvisualization for primaryand secondary insertions. | Identical |
| ApplicationSites | AbdominalThoracicGynecologic | AbdominalThoracicGynecologic | AbdominalThoracicGynecologic | Identical |
| Principles ofOperation | 1. InstallationSurgeon inserts the obturatorin the cannula.2. InsertionSurgeon makes an incisionon the patients' abdominal walland inserts the installedlaparoscopic trocar system viathe incision.3. OperationSurgeon removes theobturator from the cannula.Surgeon can insert thecorresponding diameterinstrument in the cannulabased on his/ her needs. | Unkonwn | During the operation, thetrocar sleeve and theobturator are used together.The surgeon uses theobturator to expand theincision of the abdomenand penetrates the trocarsleeve through theabdominal surface of thehuman body into theabdominal cavity, therebydelivering gas to theabdominal cavity andestablishing a path of entryfor endoscopicinstruments. | Identical |
| Signle use | Yes | Yes | Yes | Identical |
| OperationMode | Manually | Manually | Manually | Identical |
| Diameter | 5mm, 10mm | 5mm, 10mm, 12mm, 15mm | 5mm, 10mm, 12mm | The diametersof proposeddevice arecontained in thepredicateddevice(K201641). |
| Length | 65mm, 70mm, 95mm,105mm | 96mm, 98mm, 99mm,111mm | 100mm | Different, thedevices are alloffered in avariety oflengths toaccommodatevarious clinicaluse. |
| Feature | Proposed Device:NexPort™ Trocar System | Predicate Device:Disposable LaparoscopeTrocar (K201641) | Predicate Device:Disposable EndoscopicTrocar (K180208) | Discussion ofDifferences |
| Biocompatibility | CytotoxicitySensitizationIntracutaneous reactivityAcute systemic toxicityMaterial-mediatedpyrogenicity | CytotoxicitySensitizationIntracutaneous reactivityAcute systemic toxicityMaterial-mediatedpyrogenicity | CytotoxicitySensitizationIntracutaneous reactivityAcute systemic toxicityMaterial-mediatedpyrogenicity | Identical |
| SAL | $<=10^{-6}$ | $<=10^{-6}$ | $<=10^{-6}$ | Identical |
| Method ofSterilization | Irradiation | Ethylene Oxide sterilization | Irradiation | The proposeddevice adopts thesame method ofsterilization as itspredicated deviceDisposableEndoscopicTrocar (K180208) |
Table 5.2 Features comparison between proposed device and predicate devices
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-leaf clover design in blue and green. Below the clover is the text "MediConcepts" in a bold, blue sans-serif font, with the word "Group" appearing in a smaller font size directly underneath.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-leaf clover design with the leaves colored in blue and green. Below the clover is the text "MediConcepts" in a bold, sans-serif font, with the word "Group" appearing in a smaller font size underneath.
From the comparison summary table, the NexPort™ Trocar System is substantially equivalent to the predicated devices with regard to intended use, technological characteristics, safety and effectiveness.
- The devices are all intended for used in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
- The devices are all offered in a variety of lengths and Diameter to ● accommodate various anatomical locations and differences in patient anatomy.
- The proposed device and its predicated device Disposable Endoscopic Trocar (K180208) have the same Principles of Operation.
- . The devices are all offered with single use, the Sterilization Assurance Level (SAL) are all <= 10-6, and proposed device adopts the same method of sterilization as its predicated device Disposable Endoscopic Trocar (K180208).
-
- Summary of Non-Clinical Tests:
NexPort Trocar System has been evaluated for biocompatibility, accelerated aging test and real-time aging test as well as shelf life, sterilization, and mechanical safety, meantime in vivo study was conducted on porcine model to evaluate the penetration force, fixation force and tip integrity have been found to conform to applicable medical device safety standards. The NexPort Trocar System complies with below voluntary standards:
ANSI AAMI ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-lobed shape in blue and green, resembling a stylized flower or clover. Below the shape, the text "MediConcepts" is written in a bold, sans-serif font, with the word "Group" appearing underneath in a smaller font size.
ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
ANSI AAMI ISO 10993-5: 2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI AAMI ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
ANSI AAMI ISO 11137-1: 2006/(R)2015 Sterilization of health care products -Radiation - Part 1: Requirements for development.
ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose.
ANSI AAMI ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ANSI AAMI ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ASTM F1140/F1140M-13: 2020(E1) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F1980-16 Sterile hypodermic needles for single use - Requirements and test methods.
The following quality assurance measures are applied to the development of the system:
- . Risk Analysis
- Performance testing (Verification) ●
- Safety testing (Verification) ●
The NexPort Trocar System is provided with sterilization and is biocompatible.
10. Conclusion
MediConcepts Group considers the NexPort Trocar System to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.