(16 days)
K 020629, K01187
Not Found
No
The document describes a mechanical infusion set and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used to infuse or inject medication subcutaneously, which directly administers a substance for therapeutic purposes (e.g., insulin for diabetes).
No.
The device is an infusion set designed to deliver fluids/medication into the body, not to diagnose a medical condition.
No
The device description clearly outlines multiple physical components made of materials like PTFE and stainless steel, and the performance studies reference standards for physical medical devices like catheters and sterilization.
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 for infusion and/or injection of fluids into the body 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 a system for subcutaneous infusion of medication, including a catheter, tubing, and connectors. This aligns with a drug delivery device, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly described as an infusion set for delivering medication subcutaneously, which falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Simplicity Simplex P Infusion Set is to provide a means for infusion and/or injection of fluids into the body the surface of the skin when attached to a MiniMed Paradigm pump or syringe.
Product codes
FPA
Device Description
Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.
The Simplicity Simplex P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use.
The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector.
The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube.
The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless stcel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
people with diabetes
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 both I Criol mance bata Bappor this Decessions Medivations Simplicity Simplex Infusion Sct FDA 5 . 0(x) K010373 meet 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 Stcrile, single use intravascular catheters (Part 5: Peripheral Catheters). .
- ISO 11135:1994 Medical devices -- Validation and routine control of cthylenc oxide sterilization .
- 100 11133.1794 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. 9
- ISO 11607: 1997 Packaging for terminally sterilized medical devices. .
- ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. .
- 100 0355. 1991 bearing of the Limulus Amebocyte Lysate (LAL) Test as an end product . PDA Onlines on validation of the Enemeral 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 adhcred to is the Center for Devices and Radiological Health. DESC(GN And the ucsign process bances to is and Comes CTURERS. This Guid: acc CONTROL GOLDANCE FOR MEDICAL DE . CONTRO 9001. This is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 020629, K01187
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 0 3 2002
Sterling Medivations, Inc. 66 Neptune Drive Groton, CT 06340 650-814-4083(voice) 770-242-3178(fax)
510(k) SUMMAKY
Date Submitted: April 16, 2001
| Submitter: | Sterling Medivations, Inc. 66 Neptune Drive, Groton, CT 06340
Company Phone 650-814-4083, Company Fax 770-242-3178 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Jocl Douglas, Chief Technology Officer
Sterling Medivations, Inc.
Applicant Phone 650-814-4083
Applicant Fax 770-242-3178 | |
| Trade Name of Device: | Simplicity™ Simplex P Infusion Set for use with
the MiniMed Paradigm infusion pumps. | |
| Common Name of Device: | Intravascular administration set. | |
| Classification Name: | Percutaneous intravascular catheter. | |
| Predicate Device | Sterling Medivations, Sterling Medivations | |
Sterling Medivations Sterling Medivations Simplicity Simplex Soft Infusion Set, FDA 510 (k) K 020629 and Sterling Medivations Simplicity Soft YP Infusion Set K01187.
Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.
The Simplicity Simplex P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use.
The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector.
The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube.
The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless stcel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub
Sterling Mcdivations, Inc. Simplicity Simplex P Infusion Set 510(k) Summary l'age 1 of 2
1
connector.
Intended Use of the New Device: The intended use of the Simplicity Simplicx P Infusion Set is to provide a means to infose or inject medication subcutaneously when attached to the Minibed Paradigm infinion pump or syringc. The Simplicity Simplex Infision Set is substantially equivalent to the Sterling pulling of Syring. "The Bimplex Set K011187 and Simplicity Simplex Soft Infusion Set, ITTA S10 (k) K 020629.
Comparison of the Technological Features of the New Device and Predicate Device:
The Simplicity Simplex P Infusion Set proposed for conmercial distributor in similar in all signification The onlinessy Business I Thereon Simplicity Soft YP Infusion Set K011187 and Simplicity Simplex Soft Infusion Set, FDA 510 (k) K 020629.
The matcrials and manufacturing processes are substantially equivalcnt, the labeling is substantially equivalent and it has the same intended use as the Sterling Medivations Simplicity Simplicity Simplex P Infusion.
The differences that exist between the new and predicate device are as follows:
-
The new device proximal end is a Simplicity YP connector consisting of needle hub and reusable 1. pump adapter and reservoir connector used to attach to a MiniMed Paradigm infusion pu mps and pullip adapter and reservour comments asserts the Sterling Medivations Simpling Simpling Simples of YP Infusion Set K011187 and the Device otherwise similar to the Simplicity Simplicity Simplex Soft . Infusion Set, FDA 510 (k) K 020629.
Performance Data Supporting Substantial Equivalence: To prove substantial equivalence both I Criol mance bata Bappor this Decessions Medivations Simplicity Simplex Infusion Sct FDA 5 . 0(x) K010373 meet 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 Stcrile, single use intravascular catheters (Part 5: Peripheral Catheters). .
-
ISO 11135:1994 Medical devices -- Validation and routine control of cthylenc oxide sterilization .
-
100 11133.1794 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. 9
-
ISO 11607: 1997 Packaging for terminally sterilized medical devices. .
-
ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. .
-
100 0355. 1991 bearing of the Limulus Amebocyte Lysate (LAL) Test as an end product . PDA Onlines on validation of the Enemeral 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 adhcred to is the Center for Devices and Radiological Health. DESC(GN And the ucsign process bances to is and Comes CTURERS. This Guid: acc CONTROL GOLDANCE FOR MEDICAL DE . CONTRO 9001. This is substantially equivalent to the predicate device.
Signed,
Joel S. Douglas Chicf Technology Officer
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 66 Neptune Drive Groton, Connecticut 06340
MAY 0 3 2002
Re: K021216
Trade/Device Name: Simplicity Simplex P Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 16, 2002 Received: April 17, 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
Page 2 - Mr. Joel Douglas
You must comply with all the Act's requirements, including, but not limited to: registration r ou indst comply with art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lacelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality is a 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 910(t) promaried nowledge 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 If you desire specific ad 1100 for in vitro diagnostic devices), please contact the and additionally 21 CF (301) 594-4618. Additionally, for questions on the promotion and Office of Confightance wee, 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 the Act may be obtained from the Brumber (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
Enclosure
4
K02/2/6
510(k) Number (if known):
Device Name: Simplicity Simplex P Infusion Set
Indications For Use:
The intended use of the Simplicity Simplex P Infusion Set is to provide a means for infusion and/or injection of fluids into the body 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)
Patrice Accente
action Control, ﺔ ﺍﻟﻤ
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