(68 days)
The Direct Antibiotic Infusion Kit is intended for direct administration of mediation and/or fluids into the body. The Direct Antibiotic Infusion kit is intended for use by a physician or by a trained individual under the supervision of a physician. Any drug(s) used with this kit is (are) at the discretion of the physician and the indications for the drug should be verified and followed.
The Direct Antibiotic Infusion kit product line is a convenience kit for doctors. The Direct Antibiotic Infusion kit is designed to allow a physician or heath care provider to have the devices needed to administer antibiotics. The Direct Antibiotic Infusion kit consists of the following components: 1. Short or long term in-dwelling Catheter. 2. Suture. 3. Tubing anchor. 4. Tegaderm dressing. 5. Providone Iodine 10% ointment
The provided text describes a 510(k) premarket notification for a medical device called the "Direct Antibiotic Infusion Kit" by Summit Medical Products, Inc. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or specific study designs (like MRMC or standalone performance).
The document is a communication from the FDA regarding the "substantial equivalence" of the device to existing predicate devices. It focuses on regulatory aspects, classification, and general controls, noting that there is "no substantial equivalence for the Direct Antibiotic Infusion kit" but then states the FDA has reviewed the 510(k) and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This apparent contradiction might be explained if components of the kit are individually substantially equivalent, even if the kit as a whole has no direct equivalent.
Crucially, the FDA's letter states: "Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component." This indicates that the Povidone Iodine 10% Ointment, a drug component, falls under a different regulatory pathway.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because this document does not contain that level of detail about device testing. The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than requiring new, extensive performance studies that would typically be described with the requested metrics.
If this were a document about a new algorithm or AI device, it would be expected to include such detailed performance metrics. As it stands, this is a regulatory clearance document for a medical kit.
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FINDING BETTER WAYS TO CARE FOR PEOPLE "
(113043
Image /page/0/Picture/2 description: The image shows a logo for Summit Medical. The logo features three triangles of varying sizes, arranged in a row. The triangles are shaded in different ways, with the leftmost triangle having a textured fill, the center triangle having a lighter textured fill, and the rightmost triangle being solid black.
SUMMIT MEDICAL PRODUCTS
510(k) Summary
| Device Sponsor: | Summit Medical Products, Inc.2480 South Main Street Suite 212Salt Lake city, UT 84115 |
|---|---|
| RegistrationNumber: | 1722214 |
| Trade Names: | Direct Antibiotic Infusion Kit |
| Common Name: | Catheter Introducer Kit |
| ClassificationName: | Catheter Introducer Kit |
| Product Code: | LJS |
| RegulationNumber: | 880.5970 |
| Equivalent To: | None |
| DeviceDescription: | The Direct Antibiotic Infusion kit product line is a convenience kit for doctors.The Direct Antibiotic Infusion kit is designed to allow a physician or heath careprovider to have the devices needed to administer antibiotics. The DirectAntibiotic Infusion kit consists of the following components:1. Short or long term in-dwelling Catheter.2. Suture.3. Tubing anchor.4. Tegaderm dressing.5. Providone Iodine 10% ointment |
| Indications forUse: | The Direct Antibiotic Infusion Kit is intended for direct administration ofmediation and/or fluids into the body. The Direct Antibiotic Infusion kit isintended for use by a physician or by a trained individual under the supervision ofa physician. Any drug(s) used with this kit is (are) at the discretion of thephysician and the indications for the drug should be verified and followed. |
| SubstantialEquivalence(SE) Rational: | There is no substantial equivalence for the Direct Antibiotic Infusion kit. |
| Standards: | Standards are listed with the individual device 510K clearance |
| ContactInformation: | Marko Van AmenSummit Medical Products, IncVP of Regulatory Affairs/Quality Assurance2480 South Main Street Suite 212. Salt Lake City, UT 84115Phone: 801-352-1888. FAX: 801-352-1818 |
Summit Medical Products, Inc. | 2480 South Main, Suite 212 | Salt Lake City, Utah 84115 Phone 801-352-1888 | | Fax 801-352-1818 | | Toll-Free 877-352-1888 | | www.summitmpi.com
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 0 2011
Summit Medical Products, Inc. % Mr. Marko Van Amen VP of Regulatory Affairs and Quality Assurance 2480 S. Main Street, Suite 212 Salt Lake City, Utah 84115
Re: K113043
Trade/Device Name: Direct Antibiotic Infusion Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS, GAT, FRO, JCY Dated: October 06, 2011 Received: October 13, 2011
Dear Mr. Van Amen:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
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·专家
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
In addition, we have determined that your device kit contains Povidone Iodine 10% Ointment which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours;
Erin Keith
< Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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. Traditional 510(k) - Direct Antibiotic Infusion kit
510(k) Number :
Device Name: Direct Antibiotic Infusion Kit
Indications for Use:
The Direct Antibiotic Infusion Kit is intended for direct administration of mediation and/or fluids into the body. The Direct Antibiotic Infusion kit is intended for use by a physician or by a trained individual under the supervision of a physician. Any drug(s) used with this kit is (are) at the discretion of the physician and the indications for the drug should be verified and followed.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danil Krame for maxim
(Division . . ign=Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113043
Summit Medical Products, Inc.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”