(270 days)
Not Found
No
The description focuses on the mechanical design and safety features of an IV catheter, with no mention of AI or ML.
No
The device is used for administering fluids or drawing blood intravenously, but it does not treat or cure a disease or condition. Its primary function is a delivery or collection system, not a therapeutic intervention itself.
No.
The device is an I.V. safety catheter intended for administering or sampling fluids, not for diagnosing conditions.
No
The device description clearly details physical components such as a needle, needle hub, catheter, catheter hub, and safety mechanisms (push button or slide). Performance studies also include testing related to physical properties and biocompatibility, indicating a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This describes a procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Device Description: The description details a device for inserting a catheter into a patient's body for fluid delivery or drainage. It focuses on the physical mechanism for insertion and safety features.
- Lack of IVD Characteristics: There is no mention of analyzing a sample, detecting a substance, or providing diagnostic information based on a sample. The device's function is purely procedural (accessing the bloodstream).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device is a tool for accessing the body, not for analyzing a sample from it.
N/A
Intended Use / Indications for Use
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks.
The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated.
The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference.
The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G
Orange = 14G
Grey = 16G
Green = 18G
Pink = 20G
Blue = 22G
Yellow = 24G
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
any patient population
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)
Performance Testing:
- ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: Over-. needle peripheral catheters
- ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: General . requirements
- ISO 594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other . medical equipment. - Part 1: General requirements
- . ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps . protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- Simulated Clinical Use Study
Biocompatibility:
- ISO 10993-5: 2009(E) Biological evaluation of medical devices Part 5: Tests for . in vitro cytotoxicity
- ISO 10993-10: 2010 (E) Biological evaluation of medical devices Part 10: Tests ● for irritation and skin sensitization
- . USP General Chapter Pyrogen Test
- ISO 10993-11: 2017(E) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ISO 10993-4: 2017 (E) Biological evaluation of medical devices Part 4: Selection . of tests for interactions with blood
- ISO 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance ● on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for ● genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-6:2016(E) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- . ASTM F2888-19 Standard Practice for Platelet Leukocyte Count-An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
- ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-● Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
Sterility:
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements ● for the development, validation and routine control of a sterilization process for medical devices
- ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
- . ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and . Medical Devices
- ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier ● Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical ● Packaging by Dye Penetration
Key results:
The differences between The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter and the predicate did not raise new or different questions of safety and effectiveness. Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device.
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.
The MedSource IV Safety Catheter
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
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September 15, 2023
MedSource International LLC Emilie Andrews Quality and Regulatory Compliance Engineer 8600 Shelby Court, Suite 100 Chanhassen, Minnesota 55317
Re: K223788
Trade/Device Name: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 15, 2023 Received: August 16, 2023
Dear Emilie Andrews:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223788
Device Name
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
Indications for Use (Describe)
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.
| 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
MEDSOURCELABS
K223788 - 510(k) Summary
Date of Prepared: September 15, 2023
A. Submitter:
MedSource International, LLC 8600 Shelby Court Chanhassen, MN 55317
B. Contact Person:
Emilie Andrews, Regulatory and Quality Compliance Engineer 8600 Shelby Court Chanhassen, MN 55317 Phone: 952-220-8875
C. Proposed Device:
Product Code: FOZ
Trade Name: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
Common Name: Short-Term Less Than 30 Days, Therapeutic, Intravascular Catheter
Classification Name: Intravascular catheter
Regulatory Reference: 21 CFR §880.5200
Review Panel: General Hospital
Classification: Class II
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D. Predicate:
510(K): K161779
Product Code: FOZ
Trade Name: MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter
Common Name: Short-Term Less Than 30 Days, Therapeutic, Intravascular Catheter
Classification Name: Intravascular catheter
Regulatory Reference: 21 CFR §880.5200
Review Panel: General Hospital
Classification: Class II
E. Indications for Use:
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.
F. Device Description:
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks.
5
Image /page/5/Picture/2 description: The image shows the logo for MEDSOURCELABS. The text is in a bold, sans-serif font and is black. To the right of the text is a cluster of colorful hexagons.
The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated.
The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference.
The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G
| Orange = 14G | Grey = 16G | Green = 18G | Pink = 20G |
|---|---|---|---|
| Blue = 22G | Yellow = 24G |
G. SUMMARY OF COMPARISON TABLE OF PROPOSED DEVICE and PREDICATE
The proposed device is substantially equivalent to the predicate device the MedSource TrueSafe Safety I.V. Catheter (K161779). The MedSource IV Safety Catheter is also used as a reference device.
| Comparison
Point | Submission Device | Predicate Device | Discussion
n | Comments |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The MedSource
TrueSafe Blood
Control I.V. Safety
Catheter, and the
MedSource ClearSafe | The MedSource
Truesafe Safety I.V.
Catheter and the
MedSource TrueSafe | | |
| | Blood Control I.V.
Safety Catheter | Comfort Safety I.V.
Catheter
(K161779) | | |
| Indications
for Use | The MedSource
TrueSafe Safety IV
Catheter and the
MedSource TrueSafe
Comfort Safety IV
Catheter is indicated
to sample blood or
administer fluids
intravenously. The
MedSource TrueSafe
Safety IV Catheter
and the MedSource
TrueSafe Comfort
Safety IV Catheter
may be used for any
patient population
with consideration
given to adequacy for
the vascular anatomy
appropriateness for
the solution being
administered and
duration of the
therapy. | The MedSource
TrueSafe Blood
Control I.V. Safety
Catheter, and the
MedSource ClearSafe
Blood Control I.V.
Safety Catheter are
indicated to sample
blood or administer
fluids intravenously.
The MedSource
TrueSafe Blood
Control I.V. Safety
Catheter and the
MedSource ClearSafe
Blood Control I.V.
Safety Catheter may
be used for any
patient population
with consideration
given to adequacy for
the vascular anatomy,
appropriateness for
the solution being
administered and
duration of the
therapy | Same | |
| Principles of
Operations | The needle is inserted
to gain vascular
access. Then blood
will fill the flashback
chamber. After the
needle is placed it
will be removed from | The needle is inserted
to gain vascular
access. Then blood
will fill the flashback
chamber. After the
needle is placed it
will be removed from | Same | |
| | the catheter leaving
the catheter behind to
allow for vascular
access. As the needle
is removed the needle
is encapsulated inside
the catheter body. | the catheter leaving
the catheter behind to
allow for vascular
access. As the needle
is removed the needle
is encapsulated inside
the catheter body. | | |
| | | | | |
| Catheter
Outer
Dimensions
(O.D.) in
mm | 24G - 0.7
22G - 0.9
20G - 1.1
18G - 1.3
16G – 1.8
14G - 2.1 | 24G - 0.7
22G - 0.9
20G - 1.1
18G - 1.3
16G - 1.7
14G – 2.1 | Same | |
| Catheter
Effective
Length in
mm | Gauge Length
24G 19
22G 25
20G - TrueSafe 30
20G - ClearSafe 32
18G - TrueSafe 30
18G - ClearSafe 32
16G - TrueSafe 30
16G - ClearSafe 32
14G - TrueSafe 45 | Gauge Length
24G 19
22G 25
20G 25
18G 25
16G 30
14G 45 | Differen
t | Clinical simulated use
was conducted to
validate the addition
of the blood control
valve did not change
the effectiveness of
the device.
Performance testing
was done to ISO
10555-5 and ISO
10555-1 to verify
there was no change
to the effectiveness of
the device
Based on the testing
done the catheter |
| Number of
Lumen(s) | Single Lumen | Single Lumen | Same | between the two IV
Catheters does not
affect the safety anddevice. |
| Shape of
Lumen(s) | Catheter hub –
cylindrical with a
taper down to the
catheter | Catheter hub –
cylindrical with a
taper down to the
catheter | Same | |
| Flow Rate
for Each
Lumen(s) in
mL/min | Gauge Flow Rate
24G – TrueSafe 18
24G – ClearSafe 20
22G – TrueSafe 33
22G – ClearSafe 36
20G – TrueSafe 55
20G – ClearSafe 61
18G – TrueSafe 85
18G – ClearSafe 94
16G 200
14G 270 | Gauge Flow Rate
24G 20
22G 36
20G 61
18G 92
16G 220
14G 297 | Different | Flow rate variance
between the two IV
Catheters is within
the allowance in ISO
10555-1 ANNEX -E
This does not raise
new or different
questions of safety or
effectiveness. |
| Proximal
End
configuration | Cupper | Cupper | Same | |
| Distal End
configuration | Beveled | Beveled | Same | |
| Location of
outlets or
side ports | No ports | No ports | Same | |
| Diameter of
outlets or
side ports | Not applicable no
ports present | Not applicable no
ports present | Same | |
| Needle Stick
Prevention
Feature | Active - Manual
safety mechanism
Slide-ClearSafe and
Push button-TrueSafe | Active - Manual
safety mechanism
Push button | Same
Differen
t | Clinical simulated use
was conducted to
validate the addition
of the blood control
valve did not change
the effectiveness of
the device.
Performance testing
was done to ISO
23908:2011
Based on the results
of the testing this
difference does not
raise new or different
questions of safety or
effectiveness. |
| Sterilization | Terminal Ethylene
Oxide (EtO gas) | Terminal Ethylene
Oxide (EtO gas) | Same | |
| Catheter | Polyurethane (PUR)
/ (PTFE)
Polytetrafluoroethyle
ne | Polyurethane (PUR) /
(PTFE)
Polytetrafluoroethyle
ne | Same | |
| Needle | Stainless Steal | Stainless Steel | Same | |
| Catheter
Body | Polypropylene (PP) | K-Resin | Different | Clinical simulated use
was conducted to
validate the addition
of the blood control
valve did not change
the effectiveness of
the device.
Performance testing
was done to ISO
10555-5
ISO 10555-1, ISO
594-1 and ISO 594-2
to verify there was
not change to the
effectiveness of the
device
See the
biocompatibility in
Section H below for
the list of
biocompatibility
testing done to verify
there was no change
in safety
Based on the results
of the testing this
difference does not
raise new or different
questions of safety or
effectiveness. |
| Catheter
Holder | Polyacetal (POM) | Polyacetal (POM) | Same | |
| Needle Hub | K-Resin / MABS-T | K-Resin | Different | Clinical simulated use
was conducted to
validate the addition
of the blood control
valve did not change
the effectiveness of
the device. |
| | | | | 10555-5,
ISO 10555-1,
ISO 594-1, ISO 594-2
to verify there was
not change to the
effectiveness of the
device |
| | | | | See the
biocompatibility in
Section H below for
the list of
biocompatibility
testing done to verify
there was no change
in safety |
| | | | | Based on the results
of the testing this
difference does not
raise new or different
questions of safety or
effectiveness. |
| Blood
Control
Valve | Polypropylene (PP) /
Silicon / POM | Absent | Different | This valve is located
inside the catheter
hub. This is not
present in the
TrueSafe Safety IV
models.
This was added as an
additional feature to
help control possible
blood flow out of the
catheter hub |
| | | | | Performance testing
was done following
ISO 594-1 and
ISO 594-2 to verify |
| | | | | to the effectiveness of
the device |
| | | | | Clinical simulated use
was conducted to
validate the addition
of the blood control
valve did not change
the effectiveness of
the device. |
| | | | | See the
biocompatibility in
Section H below for
the list of
biocompatibility
testing done to verify
there was no change
in safety |
| | | | | Based on the results
of the testing this
difference does not
raise new or different
questions of safety or
effectiveness. |
| Flashback
Chamber | Polypropylene (PP) /
Polycarbonate (PC) | ABS | Different | Performance and
biocompatibility
evaluation
demonstrates that the
addition of
Polytetrafluoroethyle
ne does not raise
additional questions
of safety and
effectiveness. |
| | | | | Clinical simulated use
was conducted to
validate the addition |
| | | | | of the blood control
valve did not change
the effectiveness of
the device.
Performance testing
was done to ISO
10555-5: and ISO
10555-1 to verify
there was no change
to the effectiveness of
the device |
| | | | | See the
biocompatibility in
Section H below for
the list of
biocompatibility
testing done to verify
there was no change
in safety |
| | | | | Based on the results
of the testing this
difference does not
raise new or different
questions of safety or
effectiveness. |
| Hydrophobi
c Filter | Polyethylene (PE) | Poly-ethylene | Same | |
6
MEDSOURCELABS
7
MEDSOURCELABS
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9
MEDSOURCELABS
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MEDSOURCELABS
H. Performance Data:
i. Performance Testing:
- ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: Over-. needle peripheral catheters
- ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: General . requirements
- ISO 594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other . medical equipment. - Part 1: General requirements
- . ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps . protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- Simulated Clinical Use Study ●
ii. Biocompatibility
This device has prolonged contact with circulating blood.
- ISO 10993-5: 2009(E) Biological evaluation of medical devices Part 5: Tests for . in vitro cytotoxicity
- ISO 10993-10: 2010 (E) Biological evaluation of medical devices Part 10: Tests ● for irritation and skin sensitization
- . USP General Chapter Pyrogen Test
- ISO 10993-11: 2017(E) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ISO 10993-4: 2017 (E) Biological evaluation of medical devices Part 4: Selection . of tests for interactions with blood
- ISO 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance ● on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for ● genotoxicity, carcinogenicity and reproductive toxicity
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- ISO 10993-6:2016(E) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- . ASTM F2888-19 Standard Practice for Platelet Leukocyte Count-An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
- ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-● Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
iii. Sterilitv
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements ● for the development, validation and routine control of a sterilization process for medical devices
- ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
- . ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and . Medical Devices
- ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier ● Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical ● Packaging by Dye Penetration
I. Conclusion:
In summary, based on the indication for use, technological characteristics and performance testing, the differences between The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter and the predicate did not raise new or different questions of safety and effectiveness.