(38 days)
The intended use of the Simplicity Easy Access Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access Infusion Set is designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe. The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting the connecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector. The Simplicity Easy Access Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube. The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The with and me work is made from AISI 304 stainless steel and it is connecting tubing. The connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.
This document describes the 510(k) submission for the Simplicity™ Easy Access Infusion Set, which is a medical device for infusion and/or injection of fluids below the skin. The submission focuses on demonstrating substantial equivalence to a predicate device, the Maersk Medical Pureline™ Comfort™ Infusion Set (K972135).
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1. Table of Acceptance Criteria and the Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table with numerical values (e.g., minimum tensile strength of X, actual measured tensile strength of Y). Instead, it states that the device "meets the catheter requirements of" a list of ISO standards and FDA regulations, implying that compliance with these standards serves as the acceptance criteria.
The "reported device performance" is essentially that the device complies with these standards, asserting substantial equivalence. There are no performance metrics provided for specific functionalities like flow rate, leakage, or durability.
| Acceptance Criteria (Reference Standard/Regulation) | Reported Device Performance |
|---|---|
| CDRH 21 C.F.R. Section 880.5440 (Intravascular administration set) | Meets requirements |
| ISO 10555 (Sterile, single use intravascular catheters - Part 1: General Requirements) | Meets requirements |
| ISO 10555 (Sterile, single use intravascular catheters - Part 5: Peripheral Catheters) | Meets requirements |
| ISO 11135:1994 (Medical devices -- Validation and routine control of ethylene oxide sterilization) | Meets requirements |
| ISO 11138-2:1994 (Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization) | Meets requirements |
| ISO 594-1:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements) | Meets requirements |
| ISO 594-2:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings) | Meets requirements |
| ISO 9626: 1991 (Stainless Steel needle tubing for the manufacture of medical devices) | Meets requirements |
| ISO 11607: 1997 (Packaging for terminally sterilized medical devices) | Meets requirements |
| ISO 8535: 1991 (Sterile single use syringes, with or without needle, for insulin) | Meets requirements |
| FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end product endotoxin test for human and animal parenteral drugs, biological products, and medical devices | Meets requirements |
| ODE Blue Book Memorandum #K90-1 | Meets requirements |
| ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing) | Meets requirements |
| Design process adhered to Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001) | Substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for any test set (e.g., number of infusion sets tested). The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The "Performance Data Supporting Substantial Equivalence" section refers to adherence to standards, which implies in-house testing or testing by accredited labs, but no details on the specific data generated are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is compliance with established engineering and biological standards for medical devices, not a clinical determination requiring expert consensus on a diagnostic outcome. The document relies on adherence to published standards rather than expert evaluation of a test set.
4. Adjudication Method for the Test Set
As there's no "test set" in the sense of a set of cases requiring adjudication (e.g., images for diagnostic AI), an adjudication method is not applicable and not mentioned.
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
This document describes an infusion set, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Similar to point 5, this device is a physical infusion set, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is the compliance with established international and FDA standards for medical device manufacturing, materials, sterilization, and performance characteristics (e.g., Luer taper, biocompatibility, packaging integrity). It is an engineering and regulatory "ground truth" rather than a clinical or diagnostic one.
8. The Sample Size for the Training Set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning model, this question is not applicable. The "ground truth" for the device's development (its design specifications and performance benchmarks) would be rooted in the referenced ISO and FDA standards and guidance documents.
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JAN 1 7 2002
Sterling Medivations, Inc. 25285 La Loma Drive Los Altos Hills, CA 94022 650-949-0470 (voice) 650-949-0342 (fax
510(k) SUMMARY
Date Submitted: December 7, 2001
| Submitter: | Sterling Medivations, Inc. 25285 La Loma Drive, Los Altos Hills, CA 9 |
|---|---|
| Company Phone 952-473-7971, Company Fax 952-473-4758 |
- Joel Douglas, Chief Technology Officer Contact: Sterling Medivations, Inc. Applicant Phone 408-297-9474 ext. 0 voice mail 21 or 650-949-0470 Applicant Fax 408-297-9473 or 650-949-0342
Trade Name of Device: Simplicity™ Easy Access Infusion Set for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
| Common Name of Device: | Intravascular administration set. |
|---|---|
| Classification Name: | Percutaneous intravascular catheter. |
Medical Pureline™ Comfort™ Infusion Set, K972135. Predicate Device:
Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access Infusion Set is designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
The Simplicity Easy Access Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Maersk Medical Pureline™ Comfort™ Infusion Set, K972135 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting the connecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector.
The Simplicity Easy Access Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/syringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.
The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The with and me work is made from AISI 304 stainless steel and it is connecting tubing. The connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.
Intended Use of the New Device: The intended use of the Simplicity Easy Access Infusion Set is to provide a means to for infusion and/or injection of fluids.into the body below the surface of the skin when attached to an external pump or syringe.
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Comparison of the Technological Features of the New Device and Predicate Device:
The Simplicity Easy Access Infusion Set proposed for commercial distribution is similar in all significant respects I the cumption Maersk Medical Pureline™ Comfort™ Infusion Set, K972135 and it has the same intended use.
The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has the same intended use as the Maersk Medical Pureline Comfort Infusion Set.
The differences that exist between the new and predicate device are as follows:
- The new device has a connecting tube of Polyethylene and the predicate device has a connecting tube of 1. co-extruded connecting tube Polyethylene id and PVC OD.
- The new device has multiple stainless steel indwelling needles formed from AISI 304 stainless steel and 2. the predicate device has an indwelling catheter form from polytetrafluorthylene (PTFE).
Performance Data Supporting Substantial Equivalence: To prove substantial equivalence the Simplicity Easy Access Infusion Set meets the catheter requirements of:
- CDRH 21 C.F.R. Section 880.5440 Intravascular administration set .
- ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) .
- ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters). *
- ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization .
- ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators . for ethylene oxide sterilization.
- ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical . equipment - Part 1: General requirements,
- ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical . equipment -- Part 2: Lock fittings
- ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices. .
- ISO 11607: 1997 Packaging for terminally sterilized medical devices. .
- ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. .
- FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end product endotoxin test . for human and animal parenteral drugs, biological products, and medical devices.
- ODE Blue Book Memorandum #K90-1. �
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. .
And the design process adhered to is the Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. This is substantially equivalent to the predicate device.
Signed,
Joel S. Douglas Chief Technology Officer
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center, which is a stylized caduceus with a triple helix. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Joel S. Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583
Re: K014062
Trade/Device Name. Simplicity Easy Access Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 7, 2001 Received: December 10, 2001
Dear Mr. Douglas:
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.
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Page 2 - Mr. Douglas
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 (QS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name: Simplicity Easy Access Infusion Set
Indications For Use:
The intended use of the Simplicity Easy Access Infusion Set is to provide a means ♥ for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Patara Cuscente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(lk) Number _______________________________________________________________________________________________________________________________________________________________ 014062
§ 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.