(68 days)
None
None
No
The description details a kit of standard medical components for administering fluids and medication, with no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is a kit for administering medication, not the medication itself or a device that directly provides a therapeutic effect. It facilitates a therapy but is not therapeutic on its own.
No
Explanation: The device is described as a "convenience kit for doctors" to administer medication and/or fluids. It consists of components for infusion (catheter, tubing, etc.) and does not mention any function related to diagnosing conditions or analyzing patient data.
No
The device description explicitly lists multiple hardware components (catheter, suture, tubing anchor, dressing, ointment) that constitute the kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "direct administration of mediation and/or fluids into the body." This describes a therapeutic or procedural use, not a diagnostic one.
- Device Description: The components listed (catheter, suture, tubing anchor, dressing, ointment) are all used for administering substances into the body and maintaining the access site. They are not used to examine specimens from the body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to facilitate the delivery of substances into the body.
N/A
Intended Use / 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.
Product codes
LJS, GAT, FRO, JCY
Device Description
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 Antibusion 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or by a trained individual under the supervision of a physician.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
None
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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 212
Salt Lake city, UT 84115 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration
Number: | 1722214 |
| Trade Names: | Direct Antibiotic Infusion Kit |
| Common Name: | Catheter Introducer Kit |
| Classification
Name: | Catheter Introducer Kit |
| Product Code: | LJS |
| Regulation
Number: | 880.5970 |
| Equivalent To: | None |
| Device
Description: | 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:
- Short or long term in-dwelling Catheter.
- Suture.
- Tubing anchor.
- Tegaderm dressing.
- Providone Iodine 10% ointment |
| 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. |
| Substantial
Equivalence
(SE) Rational: | There is no substantial equivalence for the Direct Antibiotic Infusion kit. |
| Standards: | Standards are listed with the individual device 510K clearance |
| Contact
Information: | Marko Van Amen
Summit Medical Products, Inc
VP of Regulatory Affairs/Quality Assurance
2480 South Main Street Suite 212. Salt Lake City, UT 84115
Phone: 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
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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Page 3 - Mr. Marko Van Amen
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