(71 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of an infusion set, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an infusion set used to administer fluids and drugs, and collect blood samples. It does not actively treat a condition.
No.
The device is described as an infusion set for administering fluids and drugs, and for power injection of contrast media. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly details physical components like needles, tubing, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as administering fluids, drugs, and contrast media, as well as drawing blood samples, through implanted vascular access ports. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes in vivo.
- Device Description: The description details a needle, tubing, and connectors designed for accessing a port and managing fluid flow. This aligns with a device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. This device is used for direct patient access and administration/withdrawal of substances.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PTI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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)
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).
The following tests were performed:
- Priming Volume (Test Method: Per Internal Test Method)
- Gravity Flow (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements)
- Needle Insertion/Extraction Force (Test Method: ISO 10555-6: 2015 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted)
- Air Leakage (Test Method: ISO 8536-8: 2004 - Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus)
- Liquid Leakage (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements, Annex C)
- Luer Lock Fittings (Test Method: ISO 594-2: 1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment)
- Occlusion with Clamp (Test Method: Per Internal Test Method)
- Extension Tensile and % Elongation (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements)
- Power Injection Simulation (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements)
- Port Septum/Needle Evaluation for Coring (Test Method: Per Internal Test Method)
- Break Pull Test/Static Load Pull Test (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements)
- Needle to Extension Joint (Test Method: ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1)
- Corrosion Resistance (Test Method: ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires)
- Shelf Life (3 years) (Test Method: ISO 11607-1: 2009+A1:2014- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging; ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical; ISO 10555-1: 2013 - Incorporating corrigendum April 2014 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements; ASTM F-1929-15-, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; ASTM F-1140- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages)
- Shipping Test (Test Method: ISO 11607-1: 2009+A1:2014- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging; ISTA-2A-2011 - Performance Tests for Packaged-Products, Packaged-Products 150lb (68 kg) or Less; ASTM F-1929-15-, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; ASTM F-1140- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages)
- Simulated Use Study: Sharps Injury Prevention (Test Method: FDA's Guidance: Medical Devices with Sharps Injury Prevention Features)
- Living Hinge Fatigue (Test Method: Per Internal Test Method)
- Force at Break (Test Method: Per Internal Test Method)
- Evaluation of Magnetic Field Interactions, Heating, and Artifacts (Test Method: ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment; ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants; F2182-11a - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging; 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 was performed per ISO 10993-1, with biological endpoints including:
- Sensitization/Irritation (ISO 10993-10: 2010)
- Acute Systemic Toxicity (ISO 10993-11: 2006)
- Cytotoxicity (ISO 10993-5: 2009)
- Pyrogenicity (ISO 10993-11: 2006)
- Hemocompatibility (ISO 10993-4: 2002 Amended 2006)
- Material Characterization (ISO 10993-18: 2005)
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.
Not Found
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
§ 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).
0
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
2
| 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.
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:
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Office of Chief Information Officer
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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 |
3
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
4
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-LockTM
CT Safety Infusion Set
(K162271) |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Anti-coring Huber style needle
for port septum access having
a safety feature which that will
prevent accidental needle
sticks. The needle is
connected to a conventional | Anti-coring Huber style needle
for port septum access having
a safety feature which that will
prevent accidental needle
sticks. The needle is connected
to a conventional style |
| | | |
| | style extension set for
attachment to standard
IV/Drug infusion line sets. | extension set for attachment to
standard IV/Drug infusion line
sets. |
| Dimensions
or Lengths | 5/8" | 3/4" |
| 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 system 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. | 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 system 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. |
| Intended Use | The Pro-Lock™ CT Safety
Infusion Set is intended for
use in the administration of
fluids and drugs, as well as
blood sampling through
surgically implanted vascular
ports. | The Pro-Lock™ CT Safety
Infusion Set is intended for use
in the administration of fluids
and drugs, as well as blood
sampling through surgically
implanted vascular ports. |
| Gauge Sizes | 20 GA | 20 GA |
| Sterilization
Method | EO | EO |
| Materials | Cannula: Stainless Steel
Female Luer: PVC
Extension: Pellethane
Clamp: Polypropylene
Base: Polypropylene
Sleeve: PVC | Cannula: Stainless Steel
Female Luer: PVC
Extension: Pellethane
Clamp: Polypropylene
Base: Polypropylene
Sleeve: PVC |
| Performance
Testing | Maximum Infusion Rate:
11.8 cPs is 5 ml/sec for 20
gauge
Priming Volume: 0.20cc
Maximum Flow Rate: | Maximum Infusion Rate:
11.8 cPs is 5 ml/sec for 20
gauge
Priming Volume: 0.20cc
Maximum Flow Rate: |
| Test Performed | Test Method | |
| Priming Volume | Per Internal Test Method | |
| Gravity Flow | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements | |
| Needle
Insertion/Extractio
n Force | ISO 10555-6: 2015 - Intravascular catheters - Sterile
and single-use catheters - Part 6: Subcutaneous
implanted | |
| Air Leakage | ISO 8536-8: 2004 - Infusion equipment for medical
use - Part 8: Infusion equipment for use with
pressure infusion apparatus | |
| Test Performed | Test Method | |
| Liquid Leakage | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements, Annex
C | |
| Luer Lock Fittings | ISO 594-2: 1998 - Conical fittings with 6 % (Luer)
taper for syringes, needles and certain other medical
equipment | |
| Occlusion with
Clamp | Per Internal Test Method | |
| Extension Tensile
and % Elongation | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements | |
| Power Injection
Simulation | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements | |
| Port
Septum/Needle
Evaluation for
Coring | Per Internal Test Method | |
| Break Pull Test/
Static Load Pull
Test | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements | |
| Needle to
Extension Joint | ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single- | |
| Corrosion
Resistance | ISO 11070: 2014 - Sterile single-use intravascular
introducers, dilators and guidewires | |
| Shelf Life (3
years) | ISO 11607-1: 2009+A1:2014- Packaging for
terminally sterilized medical devices - Part 1:
Requirements for materials sterile barrier systems
and packaging
ASTM F1980-16, Standard guide for accelerated
aging of sterile barrier systems for medical
ISO 10555-1: 2013 - Incorporating corrigendum April
2014 - Intravascular catheters - Sterile and single-
use catheters Part 1: General Requirements
ASTM F-1929-15-, Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging
by Dye Penetration
ASTM F-1140- Standard Test Methods for Internal
Pressurization Failure Resistance of Unrestrained
Packages | |
| Shipping Test | ISO 11607-1: 2009+A1:2014- Packaging for
terminally sterilized medical devices - Part 1:
Requirements for materials sterile barrier systems
and packaging
ISTA-2A-2011 - Performance Tests for Packaged-
Products, Packaged-Products 150lb (68 kg) or Less
ASTM F-1929-15-, Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging
by Dye Penetration
ASTM F-1140- Standard Test Methods for Internal
Pressurization Failure Resistance of Unrestrained
Packages | |
| Simulated Use
Study: Sharps
Injury Prevention | FDA's Guidance: Medical Devices with Sharps
Injury Prevention Features | |
| Living Hinge
Fatigue | Per Internal Test Method | |
| Force at Break | Per Internal Test Method | |
| Evaluation of
Magnetic Field
Interactions,
Heating, and
Artifacts | ASTM F2052-15 - Standard Test Method for
Measurement of Magnetically Induced Displacement
Force on Medical Devices in the Magnetic
Resonance Environment
ASTM F2119-07 - Standard Test Method for
Evaluation of MR Image Artifacts from Passive
Implants
F2182-11a - Standard Test Method for Measurement
of Radio Frequency Induced Heating On or Near
Passive Implants During Magnetic Resonance
Imaging | |
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
5
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
6
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
7
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
8
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