(257 days)
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an infusion set used for administering fluids and drugs, and for blood sampling, which are supportive functions for diagnosis or treatment, but not therapeutic actions themselves.
No
The device is an infusion set designed for administering fluids and drugs, and for blood sampling, through implanted vascular access ports. It is not described as being for diagnostic purposes, such as identifying a disease or condition.
No
The device description clearly outlines physical components such as a needle, extension set, Luer connector, pinch clamp, and needle guard, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as being used for administering fluids, drugs, blood sampling, and power injection into the patient's central venous system through implanted ports. This is a direct interaction with the patient's circulatory system.
- Device Description: The description details a needle and tubing system designed for accessing and interacting with the body's internal environment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, or tissue in a laboratory setting.
The device described is a medical device used for direct patient care and treatment, not for in vitro diagnostic testing.
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 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 5ml/sec for 20 gauge non-coring Huber style needles.
Product codes
PTI
Device Description
The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated 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 nonremovable 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)
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 ¾" (19mm) Pro-Lock™ CT Safety Infusion Set, is equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880).
Test Performed: Priming Volume, Gravity Flow, Needle Insertion/Extraction Force, Air Leakage, Liquid Leakage, Luer Lock Fittings, Occlusion with Clamp, Extension Tensile and % Elongation, Power Injection Simulation, Port Septum/Needle Evaluation for Coring, Break Pull Test/Static Load Pull Test, Needle to Extension Joint Pull, Corrosion Resistance, Shelf Life (3 years), Shipping Test, Simulated Use Study: Sharps Injury Prevention, Living Hinge Fatigue, Force at Break, Evaluation of Magnetic Field Interactions, Heating, and Artifacts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 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 an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Medcomp® Ms. Courtney Nix Regulatory Affairs Manager, North America and EU 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K162271
Trade/Device Name: Pro-lock™ CT Safety Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Single Lumen Hypodermic Needle Regulatory Class: Class II Product Code: PTI Dated: March 20, 2017 Received: March 21, 2017
Dear Ms. 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 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.
1
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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. 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
Indications for Use
510(k) Number (if known) K162271
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 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 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) |
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3
| 510(k) SUMMARY | Traditional 510K | ||
|---|---|---|---|
| K162271 | |||
| 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: | 04/26/2017 | ||
| 2. | Proposed or Subject Device Information: | ||
| Trade Name: | Pro-Lock™ CT Safety Infusion Set | ||
| Device: | Non-Coring (Huber) Needle | ||
| Product Code: | PTI | ||
| Regulation Name: | Single Lumen Hypodermic Needle | ||
| C.F.R. Section: | 21 CFR 880.5570 | ||
| Class: | II | ||
| Regulation Medical | |||
| Specialty and Review | |||
| Panel: | General Hospital | ||
| 3. | Predicate Device Information: | ||
| 510(k) Number: | K132880 | ||
| Trade Name: | |||
| Needle | Medcomp® Power Injectable Safety Huber | ||
| Device: | Non-Coring (Huber) Needle | ||
| Product Code: | PTI | ||
| C.F.R. Section: | 21 CFR 880.5570 | ||
| Medcomp®: Pro-Lock™ CT Safety Infusion Set | Page 1 of 6 |
4
Image /page/4/Picture/0 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in red, resembling an abstract letter or symbol. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black. A registered trademark symbol is present next to the word.
1499 Delo Drive
Harlevsville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Device Description:
The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated 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 nonremovable 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.
5. 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 iniection 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-corina Huber style needles.
Comparison to Predicate Devices: 6.
The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is substantially equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880), in terms of indications for use, intended use, fluid path materials, biocompatibility, basic design, performance, labeling, and manufacturing process.
The difference between the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880), and the 20G x 34" (19mm) Pro-Lock™ CT Safety Infusion Set are the changes to the clamp material from acetal to Polypropylene, and the ergonomics of the safety feature to allow better grip during safety feature activation.
The indications for use differ in regards to the name of the device. There are no other differences in the indications for use statements.
Table 6.1: 510(K) Summary: Design Comparison Matrix
| Device | Proposed Device: | Predicate Device: |
|---|---|---|
| 20G x 3/4" (19mm) Pro- | ||
| LockTM CT Safety Infusion | ||
| Set | Medcomp® Power Injectable | |
| Safety Huber Needle | ||
| (K132880) | ||
| 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 style extension set for attachment to standard IV/Drug infusion line sets. | 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 extension set for attachment to standard IV/Drug infusion line sets. |
| Dimensions or Lengths | $3/4$ " | $1/2$ ", $3/4$ " 1", 1- $1/2$ " |
| 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® Power Injectable Safety Huber Needle is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Safety Huber Needle 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. |
| Gauge Sizes | 20 GA | 19, 20, 22 GA |
| Sterilization Method | EO | EO |
| Fluid Path Materials | Cannula: Stainless Steel | |
| Female Luer: PVC | ||
| Extension: Pellethane | Cannula: Stainless Steel | |
| Female Luer: PVC | ||
| Extension: Pellethane | ||
| Skin Contacting Materials | Clamp: Polypropylene | |
| Base: Polypropylene | ||
| Sleeve: PVC | Clamp: Acetal | |
| 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:
5ml/second 325 psi max | Maximum Infusion Rate:
11.8 cPs is 5 ml/sec for 20 gauge
Priming Volume: 0.18cc
Maximum Flow Rate:
5ml/second 325 psi max |
| Patient
Ergonomics | Lift required to engage
safety lock, when locked
needle is a blind hole, and
catch for extension tubing | Lift and squeeze required to
engage safety lock, when
locked needle is in an open
hole, and no catch for
extension tube |
Medcomp®: Pro-Lock™ CT Safety Infusion Set
5
Image /page/5/Picture/0 description: The image features the logo for medCOMP. The logo consists of a stylized, geometric shape in red, resembling a house or an abstract letter. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
6
Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape above the word "medCOMP". The word "med" is in red, and the word "COMP" is in black.
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 ¾" (19mm) Pro-Lock™ CT Safety Infusion Set, is equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880).
| 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/Extraction | |
| 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 Pull | ISO 10555-1: 2013 – Incorporating corrigendum April 2014 |
| – Intravascular catheters – Sterile and single-use catheters | |
| Part 1: General Requirements | |
| 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-Product | |
| 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 | |
| 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 |
Medcomp®: Pro-Lock™ CT Safety Infusion Set
Page 4 of 6
7
Medcomp®: Pro-Lock™ CT Safety Infusion Set
8
Image /page/8/Picture/0 description: The image shows the MedComp logo. The logo consists of a red geometric shape that resembles a stylized letter "M" or a house outline. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black.
1499 Delo Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Biocompatibility:
Biocompatibility was performed on the final, finished 20G x ¾" (19mm) 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. The biological endpoints include:
- Sensitization/Irritation: ISO 10993-10: 2010 Biological Evaluation of o Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- Acute Systemic Toxicity: ISO 10993-11: 2006 Biological Evaluation of o Medical Devices - Part 11: Tess for Systemic Toxicity
- Cytotoxicity: ISO 10993-5: 2009 Biological Evaluation of Medical o Devices - Part 10: Tests for in vitro Cytotoxicity
- Pvrogenicity: ISO 10993-11: 2006 Biological Evaluation of Medical o Devices - Part 11: Test for Systemic Toxicity
- Hemocompatibility: ISO 10993-4: 2002 Amended 2006 Biological o 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
11. Summary of Substantial Equivalence:
In conclusion, the proposed device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set, is considered substantially equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880) as demonstrated through non-clinical testing performed.