The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.

Device Description

The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.

AI/ML Overview

The provided submission focuses on establishing substantial equivalence for a medical device (MPS Acacia Safeguard Huber Device) to existing predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, such as MRMC studies, effect size, standalone performance, and ground truth methodologies for training data, are not applicable here.

The document describes non-clinical testing to demonstrate safety and performance for a medical device with a sharps injury prevention feature.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sterility: Meets FDA requirements, method per AAMI/ANSI/ISO 11135-1994, SAL of 10⁻⁶	Sterilized by ethylene oxide (EO). Maximum residual levels: EO 25ppm, ECH 25ppm, EG 250ppm. Labeled "Non-Pyrogenic" (LAL testing). Sterility assurance level (SAL) of 10⁻⁸ achieved during validation, exceeding minimum requirement.
Biocompatibility: Meets ISO 10993-1 and FDA G95-1 guidelines for external communicating devices, blood path indirect, contact duration B (>24 hours to <30 days).	All materials are identical to predicate device (K982047) for direct and indirect patient fluid contact. Tests performed: Cytotoxicity (MEM Elution), Sensitization (Guinea Pig Maximization), Irritation (Intracutaneous Reactivity), Systemic Toxicity (Acute Systemic Toxicity), and Hemocompatibility (Hemolysis Extract Method). All materials concluded to be biocompatible. No latex.
Safety Feature Activation/Deactivation: No failures in activating the protective sheath and no deactivation failures after activation.	"There were no safety feature activation or deactivation failures that occurred during the testing of the 3000 units."
Overall Simulated Clinical Performance: No other failures during simulated clinical testing.	"There were no other failures that occurred during the simulated clinical testing."
Bench Testing: Device meets product specifications.	Bench testing performed to ensure product specifications are met. (Specific specifications are not detailed in the summary).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 3,000 units
Data Provenance: The study was a "simulated clinical study" performed by Registered Nurses (RNs). The context suggests this was an in-house or contracted study to simulate real-world use of the device, likely within the United States. It is a prospective and controlled study design rather than retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated as a number, but the study was "performed by Registered Nurses (RNs)." It is implied that these RNs acted as the "experts" in evaluating the functional performance and safety features of the device in a simulated clinical setting.
Qualifications of Experts: Registered Nurses (RNs). Additional specific qualifications (e.g., years of experience with Huber devices) are not provided.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described. Given that the outcome was the absence of failures ("There were no safety feature activation or deactivation failures," "no other failures"), it suggests a pass/fail assessment per unit by the observing RNs, rather than a complex consensus or arbitration process typical of subjective diagnostic assessments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (Huber needle with a safety mechanism), not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm. Its performance is inherent in its mechanical design and function. While it has a safety mechanism, it doesn't operate as a "standalone algorithm."

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was its functional performance based on predetermined acceptance criteria in a simulated use environment. Specifically, the ground truth was the observation by trained Registered Nurses that the safety feature activated correctly and did not deactivate, and that no other failures occurred, aligning with the qualitative and quantitative (0 failures out of 3000 units) definitions of success.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model that requires a training set. The "training" for the device would have been its design, engineering, and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI model requiring a training set with established ground truth. The "ground truth" for the design of the device would be the product specifications and regulatory guidelines it aims to meet.

Summary

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

NOV 13 2003

Ka32934

510(k) Summary of Safety and Effectiveness

Page 1 of 5

1	Submitter:	MPS Acacia499 Nibus Street Suite EBrea, CA 92821Tel: 714-257-0470Fax: 714-257-0513
2	Contact:	Fergie F. Ferguson, RA/QA ManagerMPS Acacia
3	Date prepared:	October 30, 2003
4	Device trade name:	MPS Acacia Safeguard Huber Device
	Common name:	Set, Administration, Intravascular
5	Predicate device:510(k) number:Marketed by:	MPS Acacia Huber Needle Extension SetK982047MPS Acacia499 Nibus St., Suite EBrea, CA 92821
	Predicate device:510(k) number:Marketed by:	Millennium Huber Plus Safety Infusion SetK993848Millennium Medical (Aka Now Medical)696 Unionville Road, Suite 6Kennett Square, PA 19348
	Predicate device:510(k) number:Marketed by:	Luther Safety Huber Needle SetK021565Luther Research Partners3199 Airport Loop Drive, Unit ECosta Mesa, CA 92626
	Predicate device:510(k) number:Marketed by:	Lifeguard Safety Infusion SetK013871Horizon Medical ProductsOne Horizon WayManchester, CA 31816

Description: రు

6.1 The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets.
6.2 The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.

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

7 Intended Use:
The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.
8 Technological comparison to predicate device:
- The MPS Acacia Safequard Huber Device offers identical technique, usage 8.1 parameters and intended use to the predicate devices except for the needle cover safety mechanism.

9 Sterility:

9.1 The sterilization of the MPS Acacia Safequard Huber Device meets the requirements per the FDA's "Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA ODE 361, August 30, 2002", and the "ORDB 510(k) Sterility Review Guidance ODE/DGRND/ORDB 659, September 3, 1997."
9.2 The sterilization method that will be used to sterilize the MPS Acacia Safequard Huber Device will be ethylene oxide (EO).
9.3 The method used to validate the sterilization cycle is AAMI/ANSI/ISO 11135-1994.
9.4 The packaging used to maintain the device's sterility is a vented sterile barrier pouch comprised of gas penetrable lid stock heat sealed to a clear film such as Mylar of polyethylene.
9.5 The maximum residual level for EO is 25ppm, for ECH is 25ppm, and for EG is 250ppm.
9.6 The MPS Acacia Safeguard Huber Device will be labeled "Non-Pyrogenic." The method used to make the determination is by limulus amebocyte lysate (LAL) testina.
The sterility assurance level (SAL) will be a minimum of 10° 9.7
9.8 The direct and indirect patient fluid contacting components of the MPS Acacia Safequard Huber Device are manufactured of identical material to the MPS Acacia Huber Needle Extension Set, 510(k) number K982047, as listed in the predicate devices above. There are no differences in sterility challenges between the two devices since the configurations are the same. An evaluation was performed to determine that both the density and microbial challenge devices used in the sterilization were more difficult to sterilize than the Safeguard Huber Device. The density challenge device filled in a sterilization container weighed approximately 25 pounds in comparison to approximately 20 pounds for the Safeguard Huber Device. The microbial challenge device use in the sterilization validation has a more tortuous fluid pathway (more difficult for the sterilant to reach the entire area) than the Safeguard Huber Device. The Microbial challenge device contains a biological indicator that has a spore population of 3,0 x 10°. The microbial challenge device is loaded into locations within the density challenge devices during the validation. The complete

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

extermination of the spore population during the validation ensures a 108 sterility assurance level.

10 Biocompatibility:
- The direct and indirect patient fluid contacting components of the MPS Acacia 10.1 Safeguard Huber Device are manufactured of identical material to the MPS Acacia Huber Needle Extension Set, 510(k) number K982047, as listed in the predicate devices above.
- Biocompatibility testing has been performed for all of the materials used in the 10.2 manufacture of the MPS Acacia Huber Needle Extension Set based on ISO 10993-1 and FDA G95-1 guidelines.
- The processing of the material in the manufacturing and sterilization process is 10.3 the same for both the MPS Acacia Safeguard Huber Device and the substantially equivalent MPS Acacia Huber Needle Extension Set.
- 10.4 The following tests were performed:
  - 10.4.1 Cytotoxicity (MEM Elution)
  - 10.4.2 Sensitization (Guinea Pig Maximization Sensitization)
  - 10.4.3 Irritation (Intracutaneous Reactivity)
  - Systemic Toxicity (Acute Systemic Toxicity) 10.4.4
  - 10.4.5 Hemocompatibility (Hemolysis Extract Method)
- All tests concluded the materials to be biocompatible for their intended purpose. 10.5 There are no latex materials contained in the Safeguard Huber Device and there were no latex components tested during the biocompatibility evaluation.
11 Simulated Clinical Testing:
- 11.1 A simulated clinical study was performed by Registered Nurses (RN) on 3,000 units.
- 11.2 The study was performed in accordance with the FDA's "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA."
- There were no safety feature activation or deactivation failures that occurred 11.3 during the testing of the 3000 units. The ability to activate and not to deactivate the safety mechanism are the two most important features that must not fail during use.
- There were no other failures that occurred during the simulated clinical testing. 11.4
12 Non-clinical test summary:
- 12.1 Bench testing was performed to insure that the Safeguard Huber Device meets the product specifications as developed by MPS Acacia.

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

13 Data Documentation

13.1 All in-house and external lab test results and data analysis/documentation for the MPS Acacia Safeguard Huber Device, confirming items number 9 through 12 through current and past testing, are maintained in a secure manner at MPS Acacia in Brea, CA 92821. These in-house and external lab test results and data analysis/documentation, detailing the FDA and ISO acceptable criteria and standards for this proposed premarket notification clearance of the MPS Acacia Safeguard Huber Device, are available upon request and/or official inspection by any authorized agent of the U.S Food and Drug Administration.

14 Conclusion:

The MPS Acacia Safeguard Huber Device is substantially equivalent to the 14.1 products currently being legally marketed by MPS Acacia, Millennium Medical (Aka Now Medical), Luther Research Partners, and Horizon Medical Products. Below is a substantial equivalence comparison table between the MPS Acacia Safeguard Huber Device and the predicate devices, as listed:

Category	MPS AcaciaSafeguardHuber Device	MPS AcaciaHuber NeedleExtension Set	MillenniumMedical (Aka NowMedical) -Millennium HuberPlus SafetyInfusion Set	LutherResearchPartners -Luther SafetyHuber NeedleSet	HorizonMedicalProducts -LifeguardSafety InfusionSet
510(k) Number		K982047	K993848	K021565	K013871
Intended Use	1. The MPSAcacia SafeguardHuber Device isintended for usewith implantedinfusion ports forcontinuous orintermittentinfusion therapy.2. For infusion orwithdrawal of I.V.fluids, blood,blood products,and drugs.3. The SafeguardHuber Device hasa manuallyactivated sheaththat covers theneedle once it isremoved from thepatient. Thesheath will helpminimizeaccidentalneedlestickinjuries.4. Change perCDC guidelines orper hospitalprotocol.	1. The MPSAcacia HuberNeedleExtension Setis intended foruse withimplantedinfusion portsfor continuousor intermittentinfusiontherapy.2. For infusionor withdrawal ofI.V. fluids,blood, bloodproducts, anddrugs.3. Change perCDC guidelinesor per hospitalprotocol.	The Millennium HuberPlus Safety InfusionSet is a Safety IVadministration set witha non-coring, ninety-degree, right-angleHuber needle, used toaccess surgicallyimplanted vascularports. The Huberneedle is used toadminister fluids or towithdrawal blood.The Huber Plussystem facilitates saferemoval of the needleby encapsulating theneedle within theattachment wings tohelp preventneedlestick injurieswhen using the devicefor vascular portaccess.	The LutherSafety HuberNeedle Set is adevice intendedto administerdrugs to apatient from acontainerthrough asubcutaneousimplanted port.The HuberNeedle safetyneedle cover ismanuallyactivated.When thesafety feature isactivated, thedevice isdesigned to aidin theprevention ofaccidentalneedle sticks.	The LifeguardSafety InfusionSet is used toaccessimplantedvascular ports toadminister fluidsand/or towithdrawalblood. TheLifeguard SafetyInfusion Setfacilitates saferemoval of theneedle byencapsulatingthe needleduring port de-accessing tohelp preventneedlestickinjuries.
Tubing	Non-DEHP PVC	Same	Similar	Similar	Same
Needle	90° non-coringmedical gradestainless steel.	Same	Same	Same	Same
Sterility	Sterile and non-pyrogenic.	Same	Same	Same	Same

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

510(k) Summary of Safety and Effectiveness

Page 5 of 5

Packaging	Vented sterilebarrier pouch orformed traycomprised of agas penetrable lidstock heat sealedto a clear filmsuch as Mylar orformed PE.	Same	Same	Same	Same
-----------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------	------	------	------	------

14.2 The following guidance documents were used in the testing performed within sections numbers 9 through 12:
- 14.2.1 Sterilization validation The sterilization process was validated and monitored per AAMI/ANSI/ISO 11135-1994, Method C.
- 14.2.2 Biocompatibility Biocompatibility testing was performed per ISO 10993-1 and FDA G95-1, External Communicating Devices, Blood Path Indirect, Contact Duration B (>24 hours to <30 days).
- 14.2.3 Simulated Clinical Testing Simulated clinical testing was performed in accordance to the FDA's "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA; issued: December 31, 2002 ."
- 14.2.4 Bench Testing Bench testing was performed in accordance with product specifications developed in-house by MPS Acacia.

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

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the edge. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing movement or progress.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

MPS Acacia C/O Dr. Alfredo J. Quattrone Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, California 94234-7320

Re: K032934

Trade/Device Name: MPS Acacia Safeguard Huber Device Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 28, 2003 Received: October 29, 2003

Dear Dr. Quattrone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

Page 2 - Mr. Bueschel

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Cue L

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE

510(k) Number (if known): K032934

MPS Acacia Safeguard Huber Device Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palacia Crescenti

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) or

Over-The-Counter Use

(Optional Format 1-2-96)

Revised: OCT. 30, 2003

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.