(32 days)
The Maersk Medical Contour infusion set is indicated for subcutaneous delivery of appropriately labeled fluids or solutions from an external infusion pump.
The Contour Infusion Set is an infusion administration set, connecting to a medicine reservoir syringe (such as the MiniMed® reservoir, model 103, that is placed in an external infusion pump such as the MiniMed insulin pump) and inserted in the subcutaneous tissue of a user. The Maersk Medical Contour Infusion Set may be used with any microbore infusion pump reservoir which utilizes a standard Luer connector.
The administration set attaches to the reservoir/syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane.
The 25 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub.
It appears that the provided document is a 510(k) Premarket Notification for the Maersk Medical Contour Infusion Set.
Based on the content, this document is a submission to the FDA seeking clearance for a medical device by demonstrating its substantial equivalence to a predicate device. It is not a study reporting on the device's performance against specific acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such a study is not presented in this document.
The document primarily focuses on:
- Description of the new device: Maersk Medical Contour Infusion Set.
- Identification of a predicate device: Maersk Medical Comfort Infusion Set.
- Comparison of technological features: Stating substantial similarity to the predicate device.
- Intended Use/Indications for Use: Subcutaneous infusion of medicine from an external infusion pump.
- FDA's response: Letter confirming substantial equivalence and clearance to market.
In summary, there is no information in the provided text to fulfill your request regarding acceptance criteria and a study proving the device meets them. The 510(k) process is about demonstrating substantial equivalence, not typically about presenting a detailed performance study with acceptance criteria in the format you've requested.
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be 'K991759'. The characters are written in a bold, somewhat irregular style, giving them a distinct, hand-drawn appearance. The black ink contrasts sharply against the white background, making the characters easily readable.
Image /page/0/Picture/2 description: The image shows the logo for Maersk. The logo consists of a white, eight-pointed star inside of a black square. Below the square is the word "MAERSK" in a bold, sans-serif font.
Maersk Medical A/S Premarket Notification - 510(k) Contour Infusion Set
May 20, 1999
Part C. 510(k) Summary
Submitter: Maersk Medical A/S Infusion Devices, Aaholmvej 1-3, Osted, DK-4000 Roskilde, Denmark
Maersk Contact: Mr. John M. Lindskog, General Manager, Maersk Medical A/S Infusion Devices Telephone: + 45 48 16 70 00.
U.S. Contact: Don Selvey (520) 527-0107 (v/f); DonS@MiniMed.com.
Name of Device: Maersk Medical Contour™ Infusion Set.
Predicate Device: Maersk Medical Comfort™ Infusion Set
Description of the New Device: The Contour Infusion Set is an infusion administration set, connecting to a medicine reservoir syringe (such as the MiniMed® reservoir, model 103, that is placed in an external infusion pump such as the MiniMed insulin pump) and inserted in the subcutaneous tissue of a user. The Maersk Medical Contour Infusion Set may be used with any microbore infusion pump reservoir which utilizes a standard Luer connector.
The administration set attaches to the reservoir/syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane.
The 25 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub.
Intended Use of the New Device: The Contour infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion set is neither intended nor indicated for use with blood or blood products.
Comparison of the Technological Features of the New Device and Predicate Device: The Contour infusion set is substantially similar to the Comfort infusion set (a lawfully marketed predicate device). Both are intended for subcutaneous delivery of insulin or other appropriately labeled medicines from an infusion pump to the pump user. Both sets attach proximally to a reservoir by means of a Luer connector, and insert distally into the device user's subcutaneous tissues with a removable stainless steel needle and flexible cannula. The devices are made of similar materials.
Signed,
John M. Lindskog 5-20-99
date
John M. Lindskog General Manager Maersk Medical A/S
te
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DEPA
JUN 25 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maersk Medical A/S c/o Don Selvev Consultant Department of Clinical and Requlatory Affairs MiniMed Incorporated 12744 San Fernando Road Sylmar, California 91342
Re: K991759 Trade Name: Maersk Medical Contour™ Infusion Set Requlatory Class: II Product Code: FPA Dated: May 20, 1999 Received: May 24, 1999
Dear Mr. Selvey:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Mr. Selvey
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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.fda_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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Maersk Medical A/S Premarket Notification - 510(k) Contour Infusion Set
Image /page/3/Picture/1 description: The image shows the logo for Maersk. The logo consists of a white, seven-pointed star inside of a black square. Below the square is the word "MAERSK" in a bold, sans-serif font.
May 20, 1999
INDICATIONS FOR USE
510(k) Number:
| Device Name: | Maersk Medical Contour Infusion Set |
|---|---|
| Indications for Use: | The Maersk Medical Contour infusion set is indicated forsubcutaneous delivery of appropriately labeled fluids orsolutions from an external infusion pump. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Fabiano Ciccerelli
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ C
§ 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.