(176 days)
Not Found
Not Found
No
The 510(k) summary describes a standard I.V. start kit and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The provided text describes an I.V. Start Kit used for procedures, but it does not indicate that the device itself treats or cures a condition or disease. It assists in a procedure, which is not the same as being a therapeutic device.
No
The device is described as an "I.V. Start Kit" used for "performing or assisting in performing I.V. start procedures," which are treatment-related activities, not diagnostic ones.
No
The 510(k) summary describes an "I.V. Start Kit," which is a collection of physical medical products used for I.V. procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Opportunity Inc.'s I.V. Start Kit is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for performing or assisting in performing I.V. start procedures. This is a procedure performed directly on a patient, not on a sample taken from a patient for diagnostic purposes.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic function. It's a kit of medical products used for a therapeutic/procedural purpose (starting an IV).
- No Mention of Samples: IVD devices typically involve testing samples like blood, urine, tissue, etc. There is no mention of samples in the description.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The I.V. Start Kit is a collection of tools for a medical procedure, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
Opportunity Inc.'s I.V. Start Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility.
The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing I.V. start procedures.
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professional or other medical personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the left and top of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. James S. Sanders Sales Manager Opportunity, Inc. 1200 Old Skokie Road Highland Park, Illinois 60035-3028
K971088, K971089, K971090, K971091, K971093, K971095 Re: Trade Names: Opportunity Incision and Drainage Tray Opportunity Laceration Tray Opportunity Dressing Change Tray Opportunity Tracheostomy Care Kit Opportunity I.V. Start Kit Opportunity Suture Removal Kit Regulatory Class: K971088 (Unclassified) K971089 (II) K971090 (Unclassified) K971091 (Unclassified) K971093 (Unclassified) K971095 (Unclassified) Product Code: K971088 (EFQ) K971089 (KKX) K971090 (KMF) K971091 (KMF) K971093 (MGP) K971095 (EFO) Dated: Undated Received: June 18, 1997
Dear Mr. Sanders:
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 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 (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 kits and trays listed above have either been determined as substantially equivalent under the premarket notification process
1
Page 2 - Mr. James S. Sanders
(Section 510(k) of the act), or were on the market prior to Mav 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 kits and trays. 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 regulations.
In addition, we have determined that your device kit contains alcohol swabsticks, PVP swabsticks, alcohol prep pads, and PVP prep pads which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) 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 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.
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Page 2 - Mr. James S. Sanders
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 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 premarket notification" (21 CFR 807.97). 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,
Lila with
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/0 description: The image shows the logo for Opportunity, Inc., along with a received stamp. The stamp indicates that the document was received on June 18, 1997, at 12:45, by the FDA/CDRH/ODE/DMC. The page number is listed as page 1 of 1.
510(k) Number: K971093
Device Name: Opportunity I.V. Start Kit
INDICATIONS FOR USE:
Opportunity Inc.'s I.V. Start Kit is intended for use by a licensed
professional or other medical personnel as deemed appropriate by the using facility.
The intended use of the medical products assembled in these kits will not change
from the manufacturers original intended use. This kit is used for performing or assisting
in performing I.V. start procedures.
C. Lee Webb
.
(Division Sign-Off) Division of there Restorative 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
✓