The Subcutaneous Infusion Sets with Indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.

Device Description

The general description, operation, construction and use of the Maersk Medical Pureline™ Subcutaneous Infusion Sets With Indwelling Catheters has not changed as a result of the modifications. They remain sterile, non-pyrogenic, single use subcutaneous infusion sets designed to be used with commercially available infusion devices. There are two basic components provided for each device. The first is a stand-alone subcutaneous indwelling catheter. This catheter is provided as an integral assembly with a Teflon cannula, adhesive backed fixation tape, an iniection port and the female portion of a proprietary plastic "click-lock" connector. The catheter assembly comes with a stainless steel insertion cannula. The insertion cannula is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion cannula is come to the user inserted through the injection port and the inner lumen of the Teflon catheter with the needle end protruding past the tip of the catheter. The male connector is locked to the female connector on the indwelling catheter. A needle protector is assembled over the Teflon catheter and the insertion cannula. A separate male portion of the proprietary connector without the insertion cannula is provided in the package. This component is used to attach to the female connector of the catheter after the indwelling Teflon cannula has been inserted and the steel insertion cannula has been withdrawn. The connector protects the indwelling catheter when the infusion set is not attached. The second component of the Maersk Medical Subcutaneous infusion Set with Indwelling Catheter is the infusion set. The infusion set is comprised of a co-extruded tube with a female luer lock connector at the pump end and a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. In order to maintain the sterility of the infusion path, a male luer cap covers the female luer lock connector and the male "click-lock" connector comes attached to a mating female connector. The sets come packaged in blister packs sealed with paper lid stock.

AI/ML Overview

The provided text is a 510(k) summary for the "Maersk Medical Pureline™ Subcutaneous Infusion Set." It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding a device performance study, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Showed substantial equivalence to the unmodified device.
Component Security	Showed substantial equivalence to the unmodified device.
Design Equivalence	Achieved; described as "design equivalency."
Functional Testing	Achieved; part of "functional and safety testing" demonstrating substantial equivalence.
Safety Testing	Achieved; part of "functional and safety testing" demonstrating substantial equivalence.
Intended Use	No change from the predicate device; continues to be "for the infusion and/or injection of fluids into the body below the surface of the skin."
Technological Characteristics	No change from the predicate device; "not been affected by these modifications."

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. The study is described as "biocompatibility testing and component security testing," but no details on data origin or study design (retrospective/prospective) are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. The document refers to "testing" (biocompatibility and component security) rather than a study requiring expert-established ground truth in a clinical assessment sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. There is no mention of adjudication, as the tests are for biocompatibility and component security, not a diagnostic or clinical assessment requiring human expert consensus.
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:
- No. This is a medical device (infusion set) and not an AI/imaging device. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical device (infusion set) and not an AI/algorithm-based device. Therefore, standalone algorithm performance is not relevant and was not assessed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" equivalent here would be the established safety and performance standards for biocompatibility and component security for such devices. The document states "The results of the biocompatibility testing and component security testing showed the device is substantially equivalent to the unmodified device," implying comparison to established benchmarks or the predicate device's performance. Specific types of ground truth like pathology or outcomes data are not mentioned in this context.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

Summary

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·510(K) SUMMARY

K972/35

9 0 Summary of Safety and Effectiveness

AJG 26 EST

9.1 Trade/Proprietary Name: Maersk Medical Pureline™ Subcutaneous Infusion Set
Subcutaneous Infusion Set with indwelling catheter 9.2 Common/Usual Name:
9.3 Classification Name: Intravascular Administration Set
9.4 Substantial Equivalence: The modified Pureline™ Comfort™ Subcutaneous Infusion Sets are substantially equivalent to the currently marketed Pureline™ Comfort™ Subcutaneous Infusion Sets (K95018).
9.5 Device Description

(

There are two basic components provided for each device. The first is a stand-alone subcutaneous indwelling catheter. This catheter is provided as an integral assembly with a Teflon cannula, adhesive backed fixation tape, an iniection port and the female portion of a proprietary plastic "click-lock" connector. The catheter assembly comes with a stainless steel insertion cannula. The insertion cannula is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion cannula is come to the user inserted through the injection port and the inner lumen of the Teflon catheter with the needle end protruding past the tip of the catheter. The male connector is locked to the female connector on the indwelling catheter. A needle protector is assembled over the Teflon catheter and the insertion cannula. A separate male portion of the proprietary connector without the insertion cannula is provided in the package. This component is used to attach to the female connector of the catheter after the indwelling Teflon cannula has been inserted and the steel insertion cannula has been withdrawn. The connector protects the indwelling catheter when the infusion set is not attached.

The second component of the Maersk Medical Subcutaneous infusion Set with Indwelling Catheter is the infusion set. The infusion set is comprised of a co-extruded tube with a female luer lock connector at the pump end and a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. In order to maintain the sterility of the infusion path, a male luer cap covers the female luer lock connector and the male "click-lock" connector comes attached to a mating female connector. The sets come packaged in blister packs sealed with paper lid stock.

9.6 Intended Use
The Intended Use for the device has not changed. The Maersk Medical Pureline™ Subcutaneous Infusion Sets with Indwelling Catheters continue to be intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted

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independently from the infusion catheter and can be accessed for injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary "click-lock" connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped, to allow freedom from the infusion set and pump for showers, athletics or other activities.

9.7 Technological Characteristics

The technological characteristics of the deice have not been affected by these modifications.

9.8 Performance Data

The results of the biocompatibility testing and component security testing showed the device is substantially equivalent to the unmodified device.

9.9 Conclusion

Based on the design equivalency and the functional and safety testing, Maersk Medical has determined that the Maersk Medical Pureline™ Comfort™ Indwelling Subcutaneous Catheter and Infusion Sets are substantially equivalent to the devices currently marketed in the United States.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal, there is a stylized image of three abstract shapes that resemble birds in flight. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lee Leichter P/L Biomedical 7690 Cameron Circle 33912 Fort Myers, Florida

AUG 26 1997

K972135 Re : Maersk Medical Pureline Comfort Subcutaneous Trade Name: Infusion Set Requlatory Class: II Product Code: FPA Dated: May 14, 1997 Received: June 6, 1997

Dear Mr. Leichter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Leichter

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) File Number:

Maersk Medical Pureline™ Comfort™ (Disetronic Tender™) Subcutaneous Device Name: Infusion Set

The Subcutaneous Infusion Sets with Indwelling Catheters are indicated for the Indications For Use: infusion and/or injection of fluids into the body below the surface of the skin.
(Division Sign-Citi) Division of Dental, Int and General Hospital D 5 ' Olk) Number _

Prescription Use
(Per 21 CFR 801.109)

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.