SafePort(TM) Manifold (or Stopcock)

K211204 · Elcam Medical Acal · FMG · Sep 15, 2022 · General Hospital

Device Facts

• Record ID: K211204
• Device Name: SafePort(TM) Manifold (or Stopcock)
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: Sep 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SafePort™ Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

Device Story

SafePort™ Manifold is a single-use, disposable flow control device for I.V. therapy; used in OR/ICU by physicians/anesthesiologists. Device consists of a body with 1-5 side ports and handles; manual operation via handle rotation to direct fluid flow. Optional Luer Activated Valves (LAV) on side ports prevent reflux. Input: I.V. fluids, drugs, or blood products from I.V. sets. Output: Controlled delivery to patient vascular system. Benefits: Enables multi-line access, bolus injection, and sampling while maintaining closed system integrity via LAVs. Healthcare providers use output to manage patient fluid/drug administration; device design ensures compatibility with standard I.V. components.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via biocompatibility (ISO 10993), leakage (ISO 8536-10), luer compliance (ISO 80369-7/20), microbial ingress (AAMI/ISO CN27), and mechanical testing (torque, burst, flow rate, particulate matter).

Technological Characteristics

Materials: Polysulfone, Polycarbonate, Polyethylene, Liquid Silicone Rubber, Green PE Thermoplast. Principle: Manual stopcock flow control. Connectivity: Standard Luer (ISO 80369-7). Sterilization: Gamma irradiation. Form factor: 1-5 port manifold. No software/algorithm.

Indications for Use

Indicated for patients requiring I.V. fluid delivery, drug administration, blood transfusion, or pressure monitoring in OR/ICU settings. Used for flow control and conduit for I.V. fluids, drugs, and blood products.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Closed Swabable Stopcock and Minimal Residual Volume Luer-activated Swabable-stopcock (K060231)

Reference Devices

• SafePort Manifold™ (or Stopcock) (K11016)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2022

Elcam Medical ACAL % Tali Hazan Regulatory Affairs Consultant Talmed Ltd. Ramot-Naftali M.P Upper Galilee, 1383000 Israel

Re: K211204

Trade/Device Name: SafePort™ Manifold (or Stopcock) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FMG Dated: August 14, 2022 Received: August 16, 2022

Dear Tali Hazan:

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.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Wolloscheck, Ph.D. For Payal Patel 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K211204

Device Name SafePort(TM) Manifold (or Stopcock)

#### Indications for Use (Describe)

SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

Type of Use (Select one or both, as applicable):

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☑</span> |
|----------------------------------------------|---------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

> 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" symbol in orange and gray, followed by the words "Elcam" and "MEDICAL" stacked on top of each other in a dark gray sans-serif font. Below the words is the tagline "Where everything connects" in a smaller, lighter gray font.

# K211204 510(k) Summary Elcam Medical's SafePort™ Manifold (or Stopcock)

# 1. Submitter Information

Elcam Medical ACAL Kibbutz Baram Merom HaGalil, 1386000, Israel Phone: [phone] Fax: [phone] Email: [e-mail]

Contact person name: Ms. Tali Hazan - RA Consultant, Talmed Ltd. Phone: [phone] Email: [e-mail]

### 2. Date of Preparation

September 15, 2022

# 3. Identification of Predicate Devices

- 3.1. Primary Predicate Device: Closed Swabable Stopcock and Minimal Residual Volume Luer-activated Swabable-stopcock, cleared under K060231 on April 13, 2006.
- 3.2. Reference Device: SafePort Manifold™ (or Stopcock), cleared under 510(k) number K11016 on June 09, 2011.

### 4. Identification of Subject Device

Regulatory Information Regulation Name: Intravascular administration set Regulation Number: 880.5440 Product Code: FMG Common Name: I.V. Set Stopcock Proprietary/Trade name: SafePort™ Manifold (or Stopcock)

### 5. Device Description

Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation.

Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.

Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports).

..............................................................................................................................................................................

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" in orange and gray, followed by the words "Elcam" in bold, dark gray letters, stacked above the word "MEDICAL" in smaller, dark gray letters. Below the logo is the tagline "Where everything connects" in a smaller, lighter font.

Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body.

Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.

Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers.

Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:

The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants.

Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim.

All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.

# 6. Indications for Use Statement

SafePort™ Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" made of orange and gray lines on the left. To the right of the "E" is the text "Elcam" in a dark gray sans-serif font, with "MEDICAL" in a smaller font below it. Underneath the logo is the tagline "Where everything connects" in a smaller, lighter font.

### 7. Summary of Substantial Equivalence:

In all aspects the modified device discussed in this 510(k) Submission, substantial equivalency was established with the predicate device, as can be demonstrated in the table below:

| Feature | Closed Swabable Stopcock<br>and Minimal Residual<br>Volume<br>Luer-activated Swabable-<br>stopcock (MRVLS)<br><br>Primary Predicate Device<br>(K060231) | SafePort™ Manifold (or<br>Stopcock) | Technological<br>Features Differences |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Elcam Closed Swabable<br>Stopcock and MRVLS is<br>indicated for fluid flow<br>directional control and for<br>providing access port(s) for<br>administration of solutions.<br>Typical uses include pressure<br>monitoring, intravenous fluid<br>administration and transfusion. | SafePort™ Manifold (or<br>Stopcock) is a one or more<br>multiple ports product, which is<br>indicated to serve as a flow<br>control and a conduit device for<br>I.V fluids delivery to the<br>patient's vascular system. The<br>product is intended for delivering<br>I.V drugs or fluids, allowing<br>gravity feed, sampling,<br>transfusion, bolus injection and<br>elimination of reflux of fluids<br>during operation. | Same indications for<br>use. Some<br>technological<br>differences are<br>discussed below. |
| Classification | Stopcock, I.V. Set, Product<br>Code: FMG,<br>Regulation Number: 880.5440,<br>Panel: General Hospital. | Stopcock, I.V. Set, Product<br>Code: FMG,<br>Regulation Number: 880.5440,<br>Panel: General Hospital. | No difference |
| Number of female<br>side ports | One or multiple<br>(according to the end user<br>request). | One or multiple (according to<br>the end user request). | No difference |
| Principle of<br>Operation | Manual twisting of handle.<br>with LAV on the side<br>port(s). | Manual twisting of handle<br>Two alternatives for operations:<br>with female luer on the side<br>ports or with LAV on the side<br>ports. | Same LAV on the side<br>port. Female ports were<br>tested for leakage and<br>luer tests per sec. 8.4,<br>8.5, 8.12 and 8.13<br>below. |
| Usage duration | Up to 24 hours | Up to 24 hours | No difference |
| Chemical<br>Resistance (Lipid) | Up to 24 hours | Up to 24 hours | No difference |
| Maximum<br>Pressure | Up to 2 bar (29 psi) | With LAV: Up to 2 bar (29 psi)<br>Standard Port: Up to 3 bar (45<br>psi) | 3 bar maximum<br>pressure was tested for<br>leakage test per sec. 8.4 |
| Feature | Closed Swabable Stopcock<br>and Minimal Residual<br>Volume<br>Luer-activated Swabable-<br>stopcock (MRVLS)<br>Primary Predicate Device | SafePort™ Manifold (or<br>Stopcock)<br>Subject Device | Technological<br>Features Differences |
| | (K060231) | | |
| Raw materials | Fluid line and ports (body<br>including rotator)<br>• Polysulfone<br>• Polycarbonate | Fluid line and ports (body<br>including rotator)<br>Polysulfone<br>Polycarbonate | No difference |
| | Handle<br>Polyethylene | Handle<br>Polyethylene with Elastomer | Handle elastomer tested<br>for biocompatibility, |
| | Handle's Elastomer is N/A for<br>this product's handle. | Handle's Elastomer<br>Green PE Thermoplast®. | torque and burst tests<br>per sec. 8.1, 8.2-8.3, and<br>8.7 below). |
| | Luer Activated valve (LAV)<br>• LAV's Cap:<br>Polycarbonate<br>• LAV's stem:<br>Lubricated blue<br>Liquid silicone<br>rubber | Luer Activated valve (LAV)<br>• LAV's Cap:<br>Polycarbonate<br>• LAV's stem:<br>Lubricated blue Liquid<br>silicone rubber | No difference |
| | Lubricant<br>Medical Silicone Fluid | Lubricant<br>Medical Silicone Fluid | No difference |
| | Port Covers (Caps)<br>Polypropylene | Port cover (Caps)<br>Polypropylene | No difference |
| | Colorants<br>• Light Blue<br>• Green<br>• Red<br>• White<br>• Yellow<br>• Blue | Colorants<br>• Light Blue<br>• Green<br>• Red<br>• White<br>• Yellow<br>• Green (additional hue) | Green additional hued<br>cap was evaluated for<br>biocompatibility per<br>sec. 8.1 below. |
| Material<br>biocompatibility | Biocompatible according to ISO<br>10993-1 standard. | Biocompatible according to ISO<br>10993-1 standard. | No difference |
| Materials<br>compatibility with<br>sterilization agents | Gamma irradiation and EtO | Gamma irradiation and EtO | No difference |
| Feature | Closed Swabable Stopcock<br>and Minimal Residual<br>Volume<br>Luer-activated Swabable-<br>stopcock (MRVLS)<br>Primary Predicate Device<br>(K060231) | SafePort™ Manifold (or<br>Stopcock)<br>Subject Device | Technological<br>Features Differences |
| Overall Shape | Body with side female closed<br>port (LAV), distal female port<br>and proximal male port;<br>Assembled Handle (with or<br>without MRVLS<br>design) | Same as primary predicate<br>device, except for certain<br>dimensional and visual<br>improvement which do not affect<br>device overall shape and<br>specification. | Differences were<br>evaluated for<br>dimensions, leakage<br>biocompatibility and<br>luer tests per sec. 8.1,<br>8.2-8.9, 8.12-8.13 and<br>8.15-8.17 below. |
| Shelf Life | 5 years | 3 years | Reduced shelf life, does<br>not affect safety and<br>effectiveness. |
| Device Sterilization<br>method | Gamma irradiation | Gamma irradiation | No difference |

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

### Table 1: Substantial Equivalence (Comparison Table)

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol in orange and gray, followed by the text "Elcam" in a dark gray sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, bold, dark gray font. Underneath the logo is the tagline "Where everything connects" in a smaller, lighter gray font.

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for Elcam Medical. The logo consists of a stylized letter "E" in gray and orange, followed by the text "Elcam" in a dark gray sans-serif font. Below "Elcam" is the word "MEDICAL" in a similar font, but slightly smaller in size.

# Substantial Equivalence Discussion and Conclusion:

The above comparison table demonstrates that Elcam's modified SafePort™ Manifold (or Stopcock) is the same as the primary predicate device in all key features and therefore, it was concluded by Elcam that it is substantial equivalent to the predicate device. In terms of the design changes, it should be noted that all changes to the SafePort™ took place to fit production processes and marketing preferences. No changes took place to the subject device's basic specifications and testing methods. Acceptance criteria of all tests but one remained the same. A difference of 1.5 PSI in the upper limit of the handle door burst pressure was concluded as non-sensible during clinical use and therefore does not affect the device safety and effectiveness and does not alter substantial equivalence criteria.

Like the primary predicate device, the subject device has the same indications for use, including the transfusion which was added to the modified SafePort™. Both devices rely on same or highly similar technology and are classified under same classification.

Certain differences between the subject device and the primary predicate device, do not affect the device safety and effectiveness and have been further supported by the above identified reference device. These differences are hereby discussed:

The handle elastomer exist in the modified SafePort™ does not exist in the primary predicate device. While the subject device contains side female port(s) with or without swabable port(s), the primary predicate device contains only swabable side port(s). The reference device was used to leverage test methods for these features.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" made of gray and orange lines on the left. To the right of the "E" is the text "Elcam" in a dark gray sans-serif font, with the word "MEDICAL" below it in a smaller font. Below the text is the tagline "Where everything connects" in a smaller, lighter font.

The subject SafePort™ raw materials change (different elastomer grade and additional green colorant), and the design changes to the body, handle and LAV's cap, do not alter the basic shape of the device, did not raise new risks and were validated accordingly within the existing well-established specifications, test methods and acceptance criteria as discussed and presented in the 510(k) submission. Therefore, it was concluded that these changes do not affect the safety and effectiveness of the modified SafePort.

In terms of shelf life, so far, Elcam has validated the modified SafePort™ for three years which is less than the predicate device that was validated for 5 years. This difference narrows the claimed shelf life and therefore does not alter the safety and effectiveness of the modified device.

All other features as indicated in the comparison table, remains exactly the same as the predicate device.

In light of the above, it was concluded that the modified SafePort™ Manifold is substantially equivalent to its primary predicate device.

# 8. Non-Clinical Performance Testing

Performance tests were conducted successfully by Elcam in order to validate the changes presented in this 510(k) Submission using well established methods based either on recognized consensus standards or Elcam's internal existing test methods previously utilized for legally marketed devices. No deviations took place during the tests. The tests were as follows:

- 8.1. Biocompatibility tests were performed according to ISO 10993-1:2018 recognized consensus standard and additional parts for each test in conjunction with most current FDA's Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". All tests were performed on final-sterile devices. The biocompatibility tests that were conducted are:
- Cytotoxicity per ISO 10993-5:2009. 8.1.1.
- Maximization Sensitization per ISO 10993-10:2010. 8.1.2.
- 8.1.3. Intracutaneous Study per ISO 10993-10:2010.
- 8.1.4. Acute Systemic Toxicity per ISO 10993-11:2017.
- 8.1.5. Pyrogen Study - Material-Mediated per ISO 10993-11:2017.
- 8.1.6. Hemolysis per ISO 10993-4:2017.
- Complement Activation per ISO 10993-4:2017. 8.1.7.
- 8.1.8. Partial Thromboplastin Time (PTT) per ISO 10993-4:2017.
- 8.1.9. Platelet Activation per ISO 10993-4:2017.
- Initial handle torque test was conducted using method based on Elcam internal protocol 8.2. as previously used for Elcam cleared I&S Manifold (K032393).

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" in orange and gray, followed by the words "Elcam" and "MEDICAL" stacked on top of each other in a dark gray color. Below the logo is the tagline "Where everything connects" in a smaller, lighter gray font.

- 8.3. Handle stopper torque (override) test was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- 8.4. Leakage tests using pressure of 200 kPa (2 bar) and 300 kPa (3 bar) were conducted according to recognized consensus standard ISO 8536-10:2015.
- Leakage test using pressure of 50 kPa, (0.5 bar) was conducted according to recognized 8.5. consensus standard ISO 8536-10:2015.
- 8.6. Vacuum test was conducted according to recognized consensus standard ISO 8536-4:2010.
- 8.7. Handle "door" burst pressure test was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- 8.8. Chemical resistance test (Lipid resistance) for 24 hours was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- Flow rate test was conducted according to recognized consensus standard ISO 8536-8.9. 4:2010.
- 8.10. Particulate contamination test was conducted according to recognized consensus standard ISO 8536-4:2010.
- 8.11. Subvisible Particulate Matter test was conducted, according to USP <788>.
- 8.12. Luer tests were conducted according to recognized consensus standards ISO 80369-7:2016 and ISO 80369-20:2015 as follows:
- 8.12.1. Positive pressure liquid leakage.
- 8.12.2. Sub-atmospheric pressure air leakage.
- 8.12.3. Stress cracking.
- 8.12.4. Resistance to separation from axial load.
- 8.12.5. Resistance to separation from unscrewing.
- 8.12.6. Resistance to overriding.
- 8.13. Luer dimensions measurement was conducted using method based on Elcam internal protocol as previously used for Elcam cleared Stopcocks and Manifolds.
- 8.14. LAV cap wiping effectiveness was conducted according to AAMI TIR30:2011/(R)2016 standard, ISO 11737-1:2018 recognized consensus standard and with most current FDA's Guidance for Intravascular Administration Sets 510(k) submission.
- 8.15. Flow rate test was conducted according to recognized consensus standard ISO 1135-4:2015.
- 8.16. Blood leakage test in low pressure was conducted according to both ISO 1135-4:2015 and ISO 8536-10:2015 recognized consensus standards.
- 8.17. Mechanical hemolysis (main line) of the SafePort™ was conducted according to recognized consensus standards ASTM F756-17 and ISO 10993-4.
- 8.18. LAV Microbial Ingress Study was conducted in accordance with AAMI/ISO CN27:2021 and FDA Guidance on Intravascular Administration Sets 510(k), dated July 11, 2008.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" shape in orange and gray, followed by the text "Elcam" in a dark gray, sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, dark gray, sans-serif font. Underneath the text is the tagline "Where everything connects" in a smaller, lighter gray font.

- 8.19. Shelf-life package tests were conducted after sterilization, shipping simulation and accelerated aging, as follows:
- 8.19.1. Sterilization, per ISO 11137-2 and ISO 11607-1.
- 8.19.2. Shipping simulation on worst case configuration, per ISO 11607-1 and ASTM D4169.
- 8.19.3. Accelerated aging, simulating the claimed shelf-life, per ASTM F1980-16.
- 8.19.4. Packaging integrity tests after shipping simulation and Gamma sterilization were successfully conducted as follows:
- a) Bubble test, per ASTM F2096
- b) Burst test, per ASTM F1140/F1140M
- c) Peel test (manual) and a visual test after peeling, per ASTM F1886/F1886M.
- d) Peel test (mechanical), per ASTM F88/F88M.
- e) Dye test, per ASTM F1929.
- Visual tests after pretreatments (shipping, accelerated aging and gamma f) sterilization), per Elcam internal procedure.

#### 9. Clinical Test Conclusion

No clinical Study was performed for the purpose of this submission.

### 10. Substantially Equivalent (SE) Conclusion

After discussing substantial equivalency of the modified SafePort™ with its predicate device in terms of similarities and differences, intended use, and technological characteristics, it was concluded that none of the changes altered the device safety and effectiveness and that the criteria of substantial equivalence is met. The evaluation of the subject device performance tests also demonstrated that it is as safe and as effective as the legally marketed predicate devices and therefore substantial equivalent.