(71 days)
The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.
The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.
The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.
The provided text is related to a 510(k) premarket notification for a medical device called the "Pro-Lock CT Safety Infusion Set." This document describes the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.
However, the document does not describe a study that uses a test set, ground truth established by experts, or any of the metrics (like sensitivity, specificity, or AUC) typically associated with AI/ML device performance. It also does not mention an AI algorithm, human readers, or any multi-reader multi-case (MRMC) comparative effectiveness study.
The document focuses on the mechanical and material performance of a physical medical device (an infusion set) against established international standards for medical devices and biocompatibility. The acceptance criteria are the successful completion of these specified tests according to the outlined standards.
Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because the provided text is about a physical medical device and its traditional regulatory submission.
Here's what I can extract from the provided text regarding the performance evaluation of the physical device:
The document describes the performance testing of the Pro-Lock™ CT Safety Infusion Set to demonstrate its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria alongside reported numeric device performance results. Instead, it lists the tests performed and the standards adhered to, implying that meeting these standards constitutes the acceptance criteria. The narrative states that the results of these tests "effectively demonstrate the proposed device... is equivalent to the predicate device."
| Test Performed | Test Method / Standard (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Priming Volume | Per Internal Test Method | Priming Volume: 0.20cc (This is a device characteristic, not directly a "performance" in terms of pass/fail, but it indicates adherence to design specs.) |
| Gravity Flow | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Needle Insertion/Extraction Force | ISO 10555-6: 2015 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted | Implicitly met the standard during evaluation for substantial equivalence. |
| Air Leakage | ISO 8536-8: 2004 - Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus | Implicitly met the standard during evaluation for substantial equivalence. |
| Liquid Leakage | ISO 10555-1: 2013, Annex C - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Luer Lock Fittings | ISO 594-2: 1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment | Implicitly met the standard during evaluation for substantial equivalence. |
| Occlusion with Clamp | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Extension Tensile and % Elongation | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Power Injection Simulation | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Maximum Infusion Rate: 11.8 cPs is 5 ml/sec for 20 gauge (This is a stated performance spec, implicitly met to demonstrate equivalence). |
| Port Septum/Needle Evaluation for Coring | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Break Pull Test/Static Load Pull Test | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Needle to Extension Joint | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Corrosion Resistance | ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires | Implicitly met the standard during evaluation for substantial equivalence. |
| Shelf Life (3 years) | ISO 11607-1: 2009+A1:2014; ASTM F1980-16; ISO 10555-1: 2013; ASTM F-1929-15; ASTM F-1140 | Implicitly met the standards for shelf-life validation. |
| Shipping Test | ISO 11607-1: 2009+A1:2014; ISTA-2A-2011; ASTM F-1929-15; ASTM F-1140 | Implicitly met the standards for shipping integrity. |
| Simulated Use Study: Sharps Injury Prevention | FDA's Guidance: Medical Devices with Sharps Injury Prevention Features | Implicitly met the guidance for sharps injury prevention, as it's a "Safety Infusion Set" designed to prevent accidental needle sticks. |
| Living Hinge Fatigue | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Force at Break | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Evaluation of Magnetic Field Interactions, Heating, and Artifacts | ASTM F2052-15; ASTM F2119-07; F2182-11a; F2213-06; ASTM F 2503-13 | The device was evaluated against these standards for MRI compatibility, implying it met the criteria for safe use or appropriate labeling in an MRI environment. |
| Biocompatibility | ISO 10993-1: Externally communicating device, indirect blood path exposure, prolonged duration (greater than 24 hours and less than 30 days), with specific endpoints: Sensitization/Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Cytotoxicity (ISO 10993-5), Pyrogenicity (ISO 10993-11), Hemocompatibility (ISO 10993-4), Material Characterization (ISO 10993-18). | Implicitly met all specified biocompatibility endpoints according to ISO 10993 standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for individual tests. The testing seems to be laboratory-based verification and validation.
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from "non-clinical testing performed" at Medcomp®.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the type of device and testing described. Performance is based on meeting engineering and biocompatibility standards, not expert clinical assessment of diagnostic output.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against physical standards, not through expert adjudication.
5. 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. This is a physical medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used:
- The "ground truth" here is adherence to national and international engineering and biocompatibility standards (e.g., ISO, ASTM, FDA Guidance). These standards define acceptable physical properties and safety profiles for the device.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm requiring a training set and its associated ground truth establishment.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Medcomp (dba Medical Components, Inc.) Courtney Nix Regulatory Affairs Manager. North America and EU 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K171333
Trade/Device Name: Pro-Lock CT Safety Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: Julv 7, 2017 Received: July 10, 2017
Dear Courtney Nix:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Tara A. Ryan -S
for
Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K171333 |
|---|---|
| Device Name | Pro-Lock™ CT Safety Infusion Set |
| Indications for Use (Describe) | The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles. |
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 | EF |
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Image /page/3/Picture/0 description: The image shows the logo for medCOMP. The logo features a stylized red and white design above the text "medCOMP". The design consists of geometric shapes, including a circle and angled lines, creating a modern and abstract look.
1499 Delp Drive Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Section 6 | 510(k) SUMMARY | Traditional 510K |
|---|---|---|
| 1. | Submitter Information: | |
| Submitter: | Medcomp® | |
| 1499 Delp Drive | ||
| Harleysville, PA 19438 | ||
| Tel: (215) 256-4201, x 2285 | ||
| Fax: (215) 256-9191 | ||
| Registration Number: | 2518902 | |
| Contact: | Courtney Nix | |
| Cnix@Medcompnet.com | ||
| Regulatory Affairs Manager: North America and EU | ||
| Date Prepared: | 05/05/2017 | |
| 2. | Proposed or Subject Device Information: | |
| Trade Name: | Pro-Lock TM CT Safety Infusion Set | |
| Device: | Non-Coring (Huber) Needle | |
| Product Code: | PTI | |
| Regulation Description: | Single Lumen Hypodermic Needle | |
| C.F.R. Section: | 21 CFR 880.5570 | |
| Class: | II | |
| Review Panel: | General Hospital | |
| 3. | Predicate Device Information: | |
| 510(k) Number: | K162271 | |
| Trade Name: | Pro-Lock TM CT Safety Infusion Set | |
| Device: | Non-Coring (Huber) Needle | |
| Product Code: | PTI | |
| C.F.R. Section: | 21 CFR 880.5570 |
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
6-1
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Image /page/4/Picture/0 description: The image shows the MedComp logo. The logo is red and white. The logo has a stylized letter "M" with a white circle in the middle. The word "medCOMP" is written in red below the stylized letter "M".
A.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Device Description:
The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.
The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.
Indications for Use:
The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous svstem with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 20 gauge non-coring Huber style needles.
Comparison to Predicate Devices: 6.
The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is substantially equivalent to the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271), in terms of indications for use, intended use, materials, biocompatibility, basic design, performance, labeling, patient user inference and manufacturing process.
The difference between the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271), and the 20G x 5/8" (15 mm) Pro-Lock™ CT Safety Infusion Set is the change in needle length from %" to 5/8" and hinge lenath from 1.164" to 1.114".
| Device | Proposed Device:20G x 5/8" (15mm) Pro-LockTM CT Safety Infusion Set | Predicate Device:20G x 3/4" (19mm) Pro-LockTMCT Safety Infusion Set(K162271) |
|---|---|---|
| Design | Anti-coring Huber style needlefor port septum access havinga safety feature which that willprevent accidental needlesticks. The needle isconnected to a conventional | Anti-coring Huber style needlefor port septum access havinga safety feature which that willprevent accidental needlesticks. The needle is connectedto a conventional style |
| style extension set forattachment to standardIV/Drug infusion line sets. | extension set for attachment tostandard IV/Drug infusion linesets. | |
| Dimensionsor Lengths | 5/8" | 3/4" |
| Indicationsfor Use | The Medcomp® Pro-Lock ™CT Safety Infusion Set isintended for use in theadministration of fluids anddrugs as well as bloodsampling through implantedvascular access ports. TheMedcomp® Pro-Lock™ CTSafety Infusion Set is alsoindicated for power injection ofcontrast media into the centralvenous system with implantedvascular access portsindicated for power injection.The maximum recommendedinfusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles. | The Medcomp® Pro-Lock ™ CTSafety Infusion Set is intendedfor use in the administration offluids and drugs as well asblood sampling throughimplanted vascular accessports. The Medcomp® Pro-Lock™ CT Safety Infusion Setis also indicated for powerinjection of contrast media intothe central venous system withimplanted vascular accessports indicated for powerinjection. The maximumrecommended infusion rate at11.8 cPs is 5 ml/sec for 20gauge non-coring Huber styleneedles. |
| Intended Use | The Pro-Lock™ CT SafetyInfusion Set is intended foruse in the administration offluids and drugs, as well asblood sampling throughsurgically implanted vascularports. | The Pro-Lock™ CT SafetyInfusion Set is intended for usein the administration of fluidsand drugs, as well as bloodsampling through surgicallyimplanted vascular ports. |
| Gauge Sizes | 20 GA | 20 GA |
| SterilizationMethod | EO | EO |
| Materials | Cannula: Stainless SteelFemale Luer: PVCExtension: PellethaneClamp: PolypropyleneBase: PolypropyleneSleeve: PVC | Cannula: Stainless SteelFemale Luer: PVCExtension: PellethaneClamp: PolypropyleneBase: PolypropyleneSleeve: PVC |
| PerformanceTesting | Maximum Infusion Rate:11.8 cPs is 5 ml/sec for 20gaugePriming Volume: 0.20ccMaximum Flow Rate: | Maximum Infusion Rate:11.8 cPs is 5 ml/sec for 20gaugePriming Volume: 0.20ccMaximum Flow Rate: |
| Test Performed | Test Method | |
| Priming Volume | Per Internal Test Method | |
| Gravity Flow | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | |
| NeedleInsertion/Extraction Force | ISO 10555-6: 2015 - Intravascular catheters - Sterileand single-use catheters - Part 6: Subcutaneousimplanted | |
| Air Leakage | ISO 8536-8: 2004 - Infusion equipment for medicaluse - Part 8: Infusion equipment for use withpressure infusion apparatus | |
| Test Performed | Test Method | |
| Liquid Leakage | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements, AnnexC | |
| Luer Lock Fittings | ISO 594-2: 1998 - Conical fittings with 6 % (Luer)taper for syringes, needles and certain other medicalequipment | |
| Occlusion withClamp | Per Internal Test Method | |
| Extension Tensileand % Elongation | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | |
| Power InjectionSimulation | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | |
| PortSeptum/NeedleEvaluation forCoring | Per Internal Test Method | |
| Break Pull Test/Static Load PullTest | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | |
| Needle toExtension Joint | ISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single- | |
| CorrosionResistance | ISO 11070: 2014 - Sterile single-use intravascularintroducers, dilators and guidewires | |
| Shelf Life (3years) | ISO 11607-1: 2009+A1:2014- Packaging forterminally sterilized medical devices - Part 1:Requirements for materials sterile barrier systemsand packagingASTM F1980-16, Standard guide for acceleratedaging of sterile barrier systems for medicalISO 10555-1: 2013 - Incorporating corrigendum April2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General RequirementsASTM F-1929-15-, Standard Test Method forDetecting Seal Leaks in Porous Medical Packagingby Dye PenetrationASTM F-1140- Standard Test Methods for InternalPressurization Failure Resistance of UnrestrainedPackages | |
| Shipping Test | ISO 11607-1: 2009+A1:2014- Packaging forterminally sterilized medical devices - Part 1:Requirements for materials sterile barrier systemsand packagingISTA-2A-2011 - Performance Tests for Packaged-Products, Packaged-Products 150lb (68 kg) or LessASTM F-1929-15-, Standard Test Method forDetecting Seal Leaks in Porous Medical Packagingby Dye PenetrationASTM F-1140- Standard Test Methods for InternalPressurization Failure Resistance of UnrestrainedPackages | |
| Simulated UseStudy: SharpsInjury Prevention | FDA's Guidance: Medical Devices with SharpsInjury Prevention Features | |
| Living HingeFatigue | Per Internal Test Method | |
| Force at Break | Per Internal Test Method | |
| Evaluation ofMagnetic FieldInteractions,Heating, andArtifacts | ASTM F2052-15 - Standard Test Method forMeasurement of Magnetically Induced DisplacementForce on Medical Devices in the MagneticResonance EnvironmentASTM F2119-07 - Standard Test Method forEvaluation of MR Image Artifacts from PassiveImplantsF2182-11a - Standard Test Method for Measurementof Radio Frequency Induced Heating On or NearPassive Implants During Magnetic ResonanceImaging |
Table 6.1: 510(K) Summary: Design Comparison Matrix
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
6-2
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Image /page/5/Picture/0 description: The image shows a logo for medCOMP. The logo features a red geometric design with a white circle on the left side. The text "medCOMP" is written in a stylized font below the geometric design, with "med" in red and "COMP" in gray.
1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
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Image /page/6/Picture/0 description: The image shows the MedComp logo. The logo consists of a red and white geometric shape above the word "medCOMP" in red and gray. The geometric shape is made up of lines and curves, and it has a white circle in the lower left corner.
1499 Delp Drive Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set, is equivalent to the predicate device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271).
Table 6.2 Bench Testing and Reference Standards:
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
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Image /page/7/Picture/0 description: The image shows a logo for medCOMP. The logo is a red and white design with a circle on the left side. The text "med" is in red and "COMP" is in gray.
1499 Delp Drive
Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com
Harleysville, PA 19438
Pull
use catheters Part 1: General Requirements
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
6-5
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Image /page/8/Picture/0 description: The image shows a logo for medCOMP. The logo features a stylized geometric shape in red and white, resembling an abstract building or structure. Below the shape, the word "med" is written in red, followed by "COMP" in gray.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
F2213-06 - Standard test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment ASTM F 2503-13 -- Standard practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Biocompatibility:
රජ
Biocompatibility was performed on the final, finished Pro-Lock™ CT Safety Infusion Set per ISO 10993-1 for an externally communicating device, with indirect blood path exposure for a prolonged duration with the body, greater than 24 hours and less than 30 days. The biological endpoints include:
- Sensitization/Irritation: ISO 10993-10: 2010 Biological Evaluation of ে Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- · Acute Systemic Toxicity: ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11: Tess for Systemic Toxicity
- Cytotoxicity: ISO 10993-5: 2009 Biological Evaluation of Medical ে থ Devices - Part 10: Tests for in vitro Cytotoxicity
- Pyrogenicity: ISO 10993-11: 2006 Biological Evaluation of Medical o Devices - Part 11: Test for Systemic Toxicity
- Hemocompatibility; ISO 10993-4: 2002 Amended 2006 Biological . Evaluation of Medical Devices - Part 4: Selection for tests for interactions with blood
- Material Characterization: ISO 10993-18: 2005 Biological Evaluation of . Medical Devices - Part 18: Chemical Characterization of Materials
Summary of Substantial Equivalence: ல்
In conclusion, the proposed device, 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set, is considered substantially equivalent to the predicate device, 20G x 34" (19mm) Pro-Lock™ CT Safety Infusion Set (K162271) as demonstrated through non-clinical testing performed.
Medcomp®: 20G x 5/8" Pro-Lock™ CT Safety Infusion Set Section 6: 510(k) Site Summary
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).