(11 days)
Not Found
No
The device description focuses on the physical components and materials of an infusion set, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are related to material and sterilization standards, not algorithmic performance.
No.
The device facilitates the administration of fluids into the body, which can include therapeutic agents, but the device itself does not exert a therapeutic effect. It is a delivery mechanism, not a treatment.
No
The device description clearly states its purpose is for "infusion and/or injection of fluids into the body below the surface of the skin," making it a therapeutic or delivery device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like PTFE, stainless steel, and polyethylene, indicating it is a hardware device for fluid infusion.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a means to for infusion and/or injection of fluids into the body below the surface of the skin". This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details components like catheters, hubs, tubing, and connectors used for subcutaneous infusion. It explicitly states it's an "infusion administration set".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering fluids into the body.
N/A
Intended Use / Indications for Use
The intended use of the Simplicity Easy P Soft 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 a MiniMed Paradigm pump or syringe.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Sterling Medivations Inc.'s ("SMI") Simplicity Easy P Soft designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into the tissue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187.
The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.
The Simplicity Easy P Soft 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 Soft Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling cannulas formed from PTFE. The connecting tubing is made from a polyethylene tube.
The indwelling cannulas formed from PTFE are introduced below the skin using and insertion ring with AISI 304 stainless steel needle is attached to the hub fixed 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 connector needle is made from AISI 304 stainless steel and it is comected to the connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To prove substantial equivalence the Simplicity Easy Soft 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 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 t 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 2 1 2002
KO21530
Sterling Medivations, Inc. 66 Neptune Drive
Groton, CT 06340 650-814-4083 (voice) 770-242-8639 (fax)
510(k) SUMMARY
Date Submitted: May 10, 2002
Sterling Medivations, Inc. 66 Neptune Drive, Groton, CT 94022 Submitter: Company Phone 650-814-4083, Company Fax 770-242-8639
Contact: Joel Douglas, Chief Technology Officer Sterling Medivations, Inc. Applicant Phone 650-814-4083 or 770-242-8639
Trade Name of Device: Simplicity™ Easy P Soft Infusion Set for infusion and/or Hection 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. |
Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912. Predicate Device:
Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity Easy P Soft designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into the tissue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187.
The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.
The Simplicity Easy P Soft 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 Soft Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling cannulas formed from PTFE. The connecting tubing is made from a polyethylene tube.
The indwelling cannulas formed from PTFE are introduced below the skin using and insertion ring with AISI 304 stainless steel needle is attached to the hub fixed 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 connector needle is made from AISI 304 stainless steel and it is comected to the connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.
Intended Use of the New Device: The intended use of the Simplicity Easy P Soft 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 a MiniMed Paradigm pump or syringe.
SK 33
HO
Page 1 of 2
II
Sterling Medivations, Inc. Simplicity Easy P Soft Infusion Set 510(k) Summary
1
Comparison of the Technological Features of the New Device and Predicate Device:
The Simplicity Easy Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 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 Simplicity Easy Soft Infusion Set.
The differences that exist between the new and predicate device are as follows:
- The Simplicity Easy P Soft Infusion Set indwelling catheter connector is designed for use with the MiniMed Paradigm pump which is equivalent to the YP connector on the Sterling Medivations Simplicity Soft YP Infusion Set K011187.
Performance Data Supporting Substantial Equivalence: To prove substantial equivalence the Simplicity Easy Soft 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 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 t 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,
Jeez
Joel S. Douglas Chief Technology Officer
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely a heading or title, possibly indicating the name of an organization or department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2002
Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 66 Neptune Drive Groton, Connecticut 06340
Re: K021530
Trade/Device Name: Simplicity Easy P Soft Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 10, 2002 Received: May 10, 2002
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 vour 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 statutes and regulations administered by other Federal agencies.
3
510(k) Number (if known):
Device Name: Simplicity Easy P Soft Infusion Set
Indications For Use:
The intended use of the Simplicity Easy P Soft 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 a MiniMed Paradigm pump or syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (PER 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Patacia Cucesute
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number -
Page 7 of 94