(21 days)
Not Found
No
The device description and performance studies focus on the physical components and material standards of an infusion set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the infusion and/or injection of fluids (which can include medications) into the body, which implies a therapeutic purpose (e.g., drug delivery).
No
The device is an infusion set designed to administer fluids into the body, not to diagnose a condition or disease. Its function is to facilitate the delivery of medication or fluids.
No
The device description explicitly details multiple hardware components made of materials like PTFE and stainless steel, and the performance studies reference standards for physical medical devices like catheters and administration sets. There is no mention of software as a component or function of the device.
Based on the provided information, 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 or monitor a condition.
- Device Description: The description details components for insertion and fluid delivery (catheters, hubs, tubing, needles). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the administration of fluids into the body.
N/A
Intended Use / Indications for Use
The intended use of the Simplicity Easy 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 an external pump or syringe.
Product codes
FPA
Device Description
Sterling Medivations Inc.'s ("SMI") Simplicity Easy Soft Infusion designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to a external pump or syringe.
The device consists of four main parts: (1) infusion catheters are 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 threaded reservoir connector and (4) an insertion needle ring.
The Simplicity Easy 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 infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/svringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling cannula formed from PTFE. The connecting tubing is made from a polyethylene tube.
The PTFE indwelling cannula are insertion needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The insertion needle is removed and the connector 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 connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the 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 Basy 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 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. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the text "K020912" at the top and the text "page 1 of 2" at the bottom. The text is handwritten and appears to be part of a document. The text "K020912" is larger and bolder than the text "page 1 of 2".
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: March 19, 2001
Sterling Medivations, Inc. 25285 La Loma Drive, Los Altos Hills, CA 94022 Submitter: Company Phone 650-949-0470, Company Fax 650-949-0342
Joel Douglas, Chief Technology Officer Contact: Sterling Medivations, Inc. Applicant Phone 650-817-4083 or 650-949-0470 Applicant Fax 408-297-9473 or 650-949-0342
Trade Name of Device: Simplicity™ Easy Soft Infusion Set for infusion an fluids into the body below the surface of the skin when attached to an external pu
Common Name of Device: Intravascular administration set. Percutaneous intravascular catheter. Classification Name:
Simplicity Easy Access Infusion Set Infusion Set, FDA 510 (k) KC Predicate Device:
Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity Easy Soft Infusion designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to a external pump or syringe.
The Simplicity Easy Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters are 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 threaded reservoir connector and (4) an insertion needle ring.
The Simplicity Easy 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 infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/svringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling cannula formed from PTFE. The connecting tubing is made from a polyethylene tube.
The PTFE indwelling cannula are insertion needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The insertion needle is removed and the connector 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 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 Soft Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the skin when attached to an external pump or syringe.
Sterling Medivations, Inc. Simplicity Easy Soft Infusion Set 510(k) Summary
Page 1 of 2 SK24
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Image /page/1/Picture/0 description: The image shows the text "K020912 page 2 of 2". The text appears to be handwritten. The top line contains a series of numbers and letters, while the bottom line indicates that it is page 2 of 2.
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 Simplicity Easy out Infusion Set Infusion Set Infusion Set, FDA 510 (k) K014062 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 Access Infusion Set, FDA 510 (k) K014062.
The differences that exist between the new and predicate device are as follows:
- The new device has 360 degree rotating infusion hub. 1.
- The new device has multiple cannula form from polytetrafluorthylene (PTFE) and the predicate device has 2. has multiple indwelling catheters formed from AISI 304 stainless steel
Performance Data Supporting Substantial Equivalence: To prove substantial equivalence the Simplicity Basy 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 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
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2002
Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583
Re: K020912
Trade/Device Name: Simplicity Easy Soft Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 19, 2002 Received: March 20, 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 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.
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. Douglas
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
Timo ay A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Simplicity Easy Soft Infusion Set
Indications For Use:
The intended use of the Simplicity Easy 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 an external 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)
Patricio Cassese
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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