ClearSafe Closed System
Device Facts
| Record ID | K261041 |
|---|---|
| Device Name | ClearSafe Closed System |
| Applicant | MedSource Labs, LLC |
| Product Code | FOZ · General Hospital |
| Decision Date | Jul 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only
Device Story
ClearSafe Closed System is an over-needle peripheral intravascular catheter for fluid administration, blood sampling, and vital sign monitoring. Device features polyurethane tubing with radiopaque stripes, a stainless steel needle, and a polycarbonate hub. During insertion, the needle is withdrawn into the hub via an active, user-activated slide mechanism; an audible click confirms the needle is locked inside, providing sharps injury protection. Available in single and dual-port configurations; dual-port models include a Y-connector and a removable needleless Luer-activated valve. Used in clinical settings by healthcare providers. Output is vascular access for infusion or monitoring. Benefits include reduced risk of needlestick injury and secure, closed-system fluid pathway.
Clinical Evidence
Bench testing only. Evaluations included mechanical integrity (tensile, burst, leakage, flow rate), dimensional verification, sharps injury protection performance (activation force, containment), connector performance (ISO 80369-7), and biocompatibility (ISO 10993 series). All tests met predefined acceptance criteria.
Technological Characteristics
Materials: Polyurethane (PUR) tubing, stainless steel needle, polycarbonate (PC) hub. Features: Active slide-shield sharps protection, barium sulfate radiopaque stripe. Sterilization: Ethylene oxide (ETO), SAL 10⁻⁶. Connectivity: Luer lock, needleless Luer-activated valve (dual-port). Standards: ISO 10555-1/5, ISO 23908, ISO 80369-7, ISO 10993.
Indications for Use
Indicated for patients requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration. Suitable for use with power injectors up to 325 psi via Luer lock connection. Contraindicated for high-viscosity fluid administration.
Regulatory Classification
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.
Predicate Devices
- BD Nexiva™ Closed IV Catheter System (K243403)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
July 10, 2026
MedSource Labs, LLC
Emilie Andrews
Regulatory and Quality Compliance Engineer
8600 Shelby Ct. Suit 100
Chanhassen, Minnesota 55317
Re: K261041
Trade/Device Name: ClearSafe Closed System
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: June 11, 2026
Received: June 12, 2026
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261041 - Emilie Andrews
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}
K261041 - Emilie Andrews
Page 3
Sincerely,
DAVID WOLLOSCHECK -S
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
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261041 | ? |
| Please provide the device trade name(s). | | ? |
| ClearSafe Closed System | | |
| Please provide your Indications for Use below. | | ? |
| The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
{4}
# 510(k) Summary
*Prepared in accordance with 21 CFR 807.92*
Date Prepared: July 9, 2026
## 1. Submitter
MedSource Labs, LLC
8600 Shelby Court, Suite 100
Chanhassen, MN 55317, USA
Phone: 952 241 8332
Contact: Emilie Andrews, Regulatory and Quality Compliance Engineer
## 2. Device Identification
Trade Name: ClearSafe Closed System
Common Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Classification Name: Intravascular catheter
Regulation Number: 21 CFR 880.5200
Product Code: FOZ
Device Class: II
510(k) Number: K261041 (this submission)
## 3. Predicate Device
Trade Name: BD Nexiva™ Closed IV Catheter System
Common Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Classification Name: Intravascular catheter
Regulation Number: 21 CFR 880.5200
Product Code: FOZ
Device Class: II
510(k) Number: K243403
Sponsor: Becton, Dickinson and Company (BD)
## 4. Device Description
The ClearSafe Closed System is a range of over-needle peripheral intravascular catheters intended for intravenous administration of fluids, blood sampling, or the monitoring of vital signs, such as blood pressure. The device is designed to provide protection for healthcare workers against accidental needlestick injury and exposure to parts of the device that have come into contact with patient's blood or other body fluids.
The indwelling polyurethane (PUR) catheter tubing has radio-opaque stripes down its length to allow visibility under x-ray. The catheter range includes both single and dual port options. The single port models have a single proximal connection point — a female Luer lock — secured to the proximal end of polyvinyl chloride (PVC) tubing attached to the catheter hub. The dual port models have two proximal connection points via a Y-connector at the end of the PVC tubing: an identical female Luer lock, and a second female Luer lock fitted with a removable needleless Luer-activated valve (LAV).
{5}
The ClearSafe Closed System is comprised of a sharp needle attached to a needle hub held within a catheter hub, which is also attached to the PVC tube. The catheter hub is hollow, allowing the needle to be withdrawn inside using an activation slide mechanism after initial insertion. Once the needle is fully withdrawn, an audible click confirms it is safely locked inside the catheter body, leaving the catheter inserted in the patient for continued vascular access. The safety mechanism is active (user-activated) and does not use springs or elastic components.
The devices are supplied sterile, non-pyrogenic, and intended for single use only. Sterilization is performed using ethylene oxide (ETO) gas to a Sterility Assurance Level (SAL) of 10⁻⁶.
The ClearSafe Closed System is available in four gauge sizes, color-coded per ISO 10555-5 (18G Green, 20G Pink, 22G Blue, 24G Yellow), in both single-port and dual-port configurations, for a total of eight model configurations. Design specifications for each device model, including gauge size and catheter length, are provided in Table 1.
Table 1: Device Specifications
| Model No. | Trade Name | Port Configuration | Gauge | Catheter Length | Hub Color |
| --- | --- | --- | --- | --- | --- |
| MS-87218 | ClearSafe Closed System | Single Port | 18G | 1.25 in (32 mm) | Green |
| MS-87220 | ClearSafe Closed System | Single Port | 20G | 1.25 in (32 mm) | Pink |
| MS-87222 | ClearSafe Closed System | Single Port | 22G | 1.00 in (25 mm) | Blue |
| MS-87224 | ClearSafe Closed System | Single Port | 24G | 0.75 in (19 mm) | Yellow |
| MS-87318 | ClearSafe Closed System | Dual Port | 18G | 1.25 in (32 mm) | Green |
| MS-87320 | ClearSafe Closed System | Dual Port | 20G | 1.25 in (32 mm) | Pink |
| MS-87322 | ClearSafe Closed System | Dual Port | 22G | 1.00 in (25 mm) | Blue |
| MS-87324 | ClearSafe Closed System | Dual Port | 24G | 0.75 in (19 mm) | Yellow |
Catheter length is measured as the nominal effective length from the hub connection to the distal tip, per HHPL-QC-TMP-35. Dual port models share identical gauge, catheter length, and hub color specifications with their single port counterparts and differ only in the addition of a Y-connector and needleless Luer-activated valve (LAV) on the second proximal port.
The following specifications are common to all eight configurations listed in Table 1: Needle material — stainless steel; Catheter hub material — polycarbonate (PC); Catheter tube material — polyurethane (PUR) with barium sulfate radiopaque stripe; Sharps injury protection mechanism — active, user-activated slide needle shield with audible lock confirmation; no spring or elastic component. Sterilization: ethylene oxide (ETO), SAL of 10⁻⁶. Use: sterile, single-use, non-pyrogenic.
### 5. Indications for Use
The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only.
### 6. Contraindications
Do not use this device for power injection without verifying a secure Luer lock connection.
Product should not be used for administration of high viscosity fluids.
### 7. Technological Characteristics Comparison to Predicate
{6}
Table 2 compares the technological characteristics of the subject device to the predicate device, the BD Nexiva™ Closed IV Catheter System (K243403).
Table 2: Technological Characteristics Comparison
| Device Characteristic | Subject Device | Predicate Device | Similarity |
| --- | --- | --- | --- |
| Device name | ClearSafe Closed System | BD Nexiva™ Closed IV Catheter System | N/A |
| Sponsor | MedSource Labs, LLC | Becton, Dickinson and Company (BD) | N/A |
| 510(k) Number | This submission (K261041) | K243403 | N/A |
| Regulation no. | 21 CFR 880.5200 | 21 CFR 880.5200 | Same as predicate |
| Regulation name | Intravascular catheter | Intravascular catheter | Same as predicate |
| Product code | FOZ | FOZ | Same as predicate |
| Device description | A range of over-needle peripheral intravascular catheters intended for intravenous administration of fluids, blood sampling, or the monitoring of vital signs, such as blood pressure. | A range of over-needle peripheral intravascular catheters intended for intravenous administration of fluids, blood sampling, or the monitoring of vital signs, such as blood pressure. | Same as predicate |
| Indications for use | The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only. | Indicated to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. May be used for any patient population with consideration given to adequacy of vascular anatomy and duration of therapy. 22-18 GA (0.9-1.3 mm) devices suitable for use with power injectors set to a maximum of 300 psi (2068 kPa) when access ports not suitable for power injection are removed. | Substantially equivalent to predicate |
| Principle of operation | Closed peripheral intravascular catheter system with integrated extension set incorporating a single port or Y (dual)-port injection site. | Closed peripheral intravascular catheter system with integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates Instaflash™ needle technology to assist with flashback visualization. | Substantially equivalent to predicate |
| Catheter configurations | Single Port; Dual Port | Single Port; Single Port with MaxZero™; Dual Port with Q-Syte™; Dual Port with Q-Syte™ and End Cap; Dual Port with MaxZero™ | Substantially equivalent to predicate – see Note 2 |
| Y-site / injection port | Y-connector to second female Luer port (dual port models only) | Y-connector to second port (dual port models); Q-Syte™ needleless connector on select configurations | Substantially equivalent to predicate – see Note 2 |
{7}
| Device Characteristic | Subject Device | Predicate Device | Similarity |
| --- | --- | --- | --- |
| Needleless valve | Removable needleless Luer-activated valve (LAV) on dual port models | Q-Syte™ needleless connector / MaxZero™ valve on select dual port configurations | Substantially equivalent to predicate – see Note 2 |
| Gauge sizes offered | 18G, 20G, 22G, 24G | 18G, 20G, 22G, 24G | Same as predicate |
| Catheter length by gauge | 24G x 0.75 in; 22G x 1.00 in; 20G x 1.25 in; 18G x 1.25 in | 24G x 0.56 in; 22G x 0.75 in; 20G x 1.00 in; 18G x 1.25 in; 1.75 in (extended length option) | Different from predicate – see Note 1 |
| Color coding | According to ISO 10555-5 | According to ISO 10555-5 | Same as predicate |
| Winged hub option | Yes | Yes | Same as predicate |
| Blood control design | Yes | Yes | Same as predicate |
| Sharps injury protection | Active mechanism with slide needle shielding | Passive mechanism with needle shielding | Different from predicate – see Note 3 |
| Catheter tube material | Polyurethane (PUR) | Polyurethane (PUR) | Same as predicate |
| Catheter tip shape | Beveled | Not specified in predicate 510(k) summary | Unable to compare to predicate – see Note 4 |
| Needle material | Stainless steel | Stainless steel | Same as predicate |
| X-ray visible | Barium sulfate stripe in catheter tube | Barium sulfate stripe in catheter tube | Same as predicate |
| Labeled for single use? | Yes | Yes | Same as predicate |
| Sterilization method | Ethylene oxide (ETO) | Ethylene oxide (ETO) | Same as predicate |
| Shelf life | 2 years | 3 years | Different from predicate – see Note 5 |
| Power injector compatible | Yes, up to 325 psi with Luer lock connection only | Yes; 22-18 GA (0.9-1.3 mm) devices suitable for use with power injectors set to a maximum of 300 psi (2068 kPa) when access ports not suitable for power injection are removed | Substantially equivalent to predicate |
| Biocompatibility | Biocompatible in accordance with ISO 10993 series and FDA guidance | Biocompatible in accordance with ISO 10993 series and FDA guidance | Same as predicate |
| MR compatibility | MR not evaluated | Not specified in predicate 510(k) summary | Unable to compare to predicate – see Note 6 |
| Environment of use | Rx Only | Rx Only | Same as predicate |
{8}
Note 1: The subject and predicate devices include the same standard gauge sizes (18G, 20G, 22G, and 24G) commonly used for peripheral intravascular access. While minor differences in catheter length are present, and the predicate offers an additional 1.75 in extended-length option not offered by the subject device, these variations fall within clinically accepted ranges and do not impact the intended use, insertion technique, or performance characteristics of the device. Therefore, these differences do not raise new questions of safety and effectiveness.
Note 2: The subject device's dual port models use a Y-connector with a removable needleless Luer-activated valve (LAV), while the predicate offers a broader range of connector options, including Q-Syte™ and MaxZero™ needleless valves, across its dual port configurations. Both approaches provide closed, needle-free access to the fluid pathway consistent with the intended use, and the difference in specific connector technology does not raise new questions of safety and effectiveness.
Note 3: Both the subject and predicate devices incorporate engineered sharps injury protection features to reduce the risk of needlestick injury after catheter use. The predicate device uses a passive safety mechanism, while the subject device utilizes an active safety mechanism requiring user activation. This represents a different design approach to achieving the same safety objective and does not alter the intended use or fundamental scientific technology. Active safety mechanisms are well-established in legally marketed devices and are consistent with sharps injury prevention principles outlined in the Needlestick Safety and Prevention Act. Risks associated with user activation have been mitigated through device design, labeling, and human factors validation testing. Therefore, this difference does not raise new questions of safety and effectiveness.
Note 4: The subject device includes a beveled catheter tip, while the predicate device tip geometry is not specified in the publicly available 510(k) summary. Beveled catheter tips are a standard design feature for peripheral intravenous catheters and are widely used to facilitate insertion. This characteristic does not represent a new or different technological approach and does not raise new questions of safety and effectiveness.
Note 5: The subject device has a labeled shelf life of 2 years, compared to 3 years for the predicate device. Shelf life is supported by stability and packaging validation testing in accordance with applicable standards. The difference in shelf life does not affect the device's intended use, performance, or safety profile and therefore does not raise new questions of safety and effectiveness.
Note 6: The predicate device does not include MR compatibility information in its 510(k) summary. The subject device has not been evaluated for MR safety and does not include MR-specific labeling. Neither device includes MR compatibility claims. Therefore, this does not represent a difference in technological characteristics and does not raise new questions of safety and effectiveness.
Conclusion: The subject and predicate devices have the same indications for use and fundamental technological characteristics. The differences identified in Table 2 do not raise different questions of safety or effectiveness. The performance data summarized in Section 8 demonstrate that the subject device is substantially equivalent to the predicate device.
### 8. Summary of Non-Clinical Performance Data
Nonclinical performance testing was conducted to support substantial equivalence and to demonstrate that the subject intravascular catheter with integrated safety mechanism performs as intended and is as safe and effective as the predicate device. Testing encompassed mechanical, functional, dimensional, connector, and sharps injury protection evaluations representative of clinical use conditions. Worst-case configurations, including smallest gauge sizes, maximum length assemblies, and aged samples (to account for sterilization and shelf life), were evaluated as applicable.
Mechanical and fluid pathway integrity: assessed through tensile force, burst pressure, liquid and air leakage, flow rate, and power injection performance testing. Results confirmed that the catheter assemblies maintain structural integrity, leak resistance, and required flow performance under simulated clinical conditions, meeting all predefined acceptance criteria.
Dimensional and physical characterization: effective length, inner and outer diameters, distal tip geometry, surface finish, and corrosion resistance were verified. All attributes met design specifications and applicable standard requirements.
{9}
Needle and safety mechanism performance: needle point quality, catheter-to-needle alignment, hub bonding strength, safety clip interaction, activation force, override resistance, free-fall resistance, and post-activation sharps accessibility were evaluated. Testing demonstrated reliable activation, secure needle containment, and effective sharps injury prevention consistent with the intended safety function.
Connector performance: tested in accordance with small-bore connector standards, including stress cracking, pressure and sub-atmospheric leakage, axial separation, resistance to unscrewing and overriding, disconnection torque, and air leakage assessments. Results demonstrated secure, leak-free connections compatible with clinical infusion systems.
Testing was performed in accordance with FDA-recognized consensus standards, including ISO 10555-1, ISO 10555-5, ISO 23908, and ISO 80369-7, or equivalent validated internal methods where appropriate. All results met predefined acceptance criteria with no failures observed. Clinical testing was not required, as bench testing was sufficient to demonstrate comparable technological characteristics and performance to the predicate device. Based on the totality of evidence, the subject device supports a determination of substantial equivalence.
## 9. Biocompatibility
This Biological Evaluation Report (BER) was conducted in accordance with FDA-recognized international standard ISO 10993-1:2018, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” Based on the intended use and the worst-case body-contacting components, the ClearSafe Closed System is classified as an external communicating device with direct and indirect contact with circulating blood, of prolonged duration (>24 hours to <30 days).
Representative samples for biocompatibility testing were selected using a worst-case approach, including the smallest and largest gauge sizes and colored components from intermediate gauges to account for potential colorant-related risks; samples were sterilized twice to represent worst case. Cytotoxicity testing was additionally performed on aged samples to assess the potential impact of material degradation and leachables over the labeled shelf life; all other endpoints were evaluated on fresh, representative samples.
In accordance with ISO 10993-1:2018 and FDA guidance, the following biological endpoints were considered relevant for this device type and were addressed through direct biological testing:
Cytotoxicity (ISO 10993-5:2009); Sensitization (ISO 10993-10:2021); Irritation or Intracutaneous Reactivity (ISO 10993-23:2021); Acute Systemic Toxicity (ISO 10993-11:2017); Subacute/Subchronic Toxicity (ISO 10993-11:2017); Hemocompatibility (ISO 10993-4:2017), comprising hemolysis (extract and direct contact), complement activation assay, partial thromboplastin time, and platelet and leukocyte count assay; Material-mediated Pyrogenicity (ISO 10993-11:2017); Genotoxicity (ISO 10993-3:2014), comprising bacterial reverse mutation and lymphoma assay; and Muscle implantation (ISO 10993-6:2016).
A traditional biological response-based testing approach was selected in lieu of chemical characterization under ISO 10993-18, consistent with the flexibility permitted by ISO 10993-1:2018. This approach was considered adequate because all relevant biological endpoints were addressed through direct biological testing on the finished, sterilized device, capturing real-world exposure conditions including any extractables, leachables, degradation products, processing residues, or sterilization residuals; all completed tests met their respective acceptance criteria; and the device materials have an established history of use in similar medical applications.
Results of this testing demonstrate that the ClearSafe Closed System does not elicit unacceptable cytotoxic, sensitization, irritation, systemic toxicity, hemocompatibility, or other adverse biological responses under the specified conditions of use. Based on the totality of evidence — materials of construction, nature and duration of patient contact, manufacturing and sterilization processes, and biocompatibility test results — the ClearSafe Closed System is considered biocompatible and suitable for its intended clinical use.
