Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical features for safety and infusion, with no mention of AI or ML.

Therapeutic

No
The description states the device is used for infusion or withdrawal of fluids, not for treating any specific condition or disease. Its primary function is a delivery mechanism, and it highlights sharps injury prevention, not therapeutic action.

Diagnostic

No
The device is described as being used for "continuous or intermittent infusion therapy" and for "infusion or withdrawal of I.V. fluids, blood, blood products, and drugs," which are therapeutic or operational functions, not diagnostic ones. Its purpose is to deliver substances or protect against needlestick injuries, not to identify a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a stainless steel needle, infusion tubing, luer lock connector, needle tip protector, luer cap, and a protective sheath mechanism. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "continuous or intermittent infusion therapy" and for "infusion or withdrawal of I.V. fluids, blood, blood products, and drugs" via implanted infusion ports. This describes a device used for administering or withdrawing substances directly from the body, not for testing samples in vitro (outside the body).
Device Description: The description details a needle and tubing system designed for transdermal access and infusion. This aligns with a device used for direct patient care and administration, not for diagnostic testing of samples.
No mention of diagnostic testing: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Focus on infusion and safety: The description emphasizes the infusion function and the safety feature to prevent needlestick injuries, which are characteristics of devices used for direct patient treatment.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the delivery or withdrawal of substances to or from the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

FPA

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.

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

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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."
11.3 There were no safety feature activation or deactivation failures that occurred 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.
11.4 There were no other failures that occurred during the simulated clinical testing.

12.1 Bench testing was performed to insure that the Safeguard Huber Device meets the product specifications as developed by MPS Acacia.

Key Metrics

Not Found

Predicate Device(s)

K982047, K993848, K021565, K013871

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

NOV 13 2003

Ka32934

510(k) Summary of Safety and Effectiveness

Page 1 of 5

| 1 | Submitter: | MPS Acacia
499 Nibus Street Suite E
Brea, CA 92821
Tel: 714-257-0470
Fax: 714-257-0513 |
|---|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Contact: | Fergie F. Ferguson, RA/QA Manager
MPS 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 Set
K982047
MPS Acacia
499 Nibus St., Suite E
Brea, CA 92821 |
| | Predicate device:
510(k) number:
Marketed by: | Millennium Huber Plus Safety Infusion Set
K993848
Millennium Medical (Aka Now Medical)
696 Unionville Road, Suite 6
Kennett Square, PA 19348 |
| | Predicate device:
510(k) number:
Marketed by: | Luther Safety Huber Needle Set
K021565
Luther Research Partners
3199 Airport Loop Drive, Unit E
Costa Mesa, CA 92626 |
| | Predicate device:
510(k) number:
Marketed by: | Lifeguard Safety Infusion Set
K013871
Horizon Medical Products
One Horizon Way
Manchester, 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 Acacia
Safeguard
Huber Device | MPS Acacia
Huber Needle
Extension Set | Millennium
Medical (Aka Now
Medical) -
Millennium Huber
Plus Safety
Infusion Set | Luther
Research
Partners -
Luther Safety
Huber Needle
Set | Horizon
Medical
Products -
Lifeguard
Safety Infusion
Set |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K982047 | K993848 | K021565 | K013871 |
| Intended Use | 1. The MPS
Acacia Safeguard
Huber Device is
intended for use
with implanted
infusion ports for
continuous or
intermittent
infusion therapy.
2. For infusion or
withdrawal of I.V.
fluids, blood,
blood products,
and drugs.
3. The Safeguard
Huber Device has
a manually
activated sheath
that covers the
needle once it is
removed from the
patient. The
sheath will help
minimize
accidental
needlestick
injuries.
4. Change per
CDC guidelines or
per hospital
protocol. | 1. The MPS
Acacia Huber
Needle
Extension Set
is intended for
use with
implanted
infusion ports
for continuous
or intermittent
infusion
therapy.
2. For infusion
or withdrawal of
I.V. fluids,
blood, blood
products, and
drugs.
3. Change per
CDC guidelines
or per hospital
protocol. | The Millennium Huber
Plus Safety Infusion
Set is a Safety IV
administration set with
a non-coring, ninety-
degree, right-angle
Huber needle, used to
access surgically
implanted vascular
ports. The Huber
needle is used to
administer fluids or to
withdrawal blood.
The Huber Plus
system facilitates safe
removal of the needle
by encapsulating the
needle within the
attachment wings to
help prevent
needlestick injuries
when using the device
for vascular port
access. | The Luther
Safety Huber
Needle Set is a
device intended
to administer
drugs to a
patient from a
container
through a
subcutaneous
implanted port.
The Huber
Needle safety
needle cover is
manually
activated.
When the
safety feature is
activated, the
device is
designed to aid
in the
prevention of
accidental
needle sticks. | The Lifeguard
Safety Infusion
Set is used to
access
implanted
vascular ports to
administer fluids
and/or to
withdrawal
blood. The
Lifeguard Safety
Infusion Set
facilitates safe
removal of the
needle by
encapsulating
the needle
during port de-
accessing to
help prevent
needlestick
injuries. |
| Tubing | Non-DEHP PVC | Same | Similar | Similar | Same |
| Needle | 90° non-coring
medical grade
stainless steel. | Same | Same | Same | Same |
| Sterility | Sterile and non-
pyrogenic. | Same | Same | Same | Same |

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510(k) Summary of Safety and Effectiveness

Page 5 of 5

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

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