(13 days)
Not Found
No
The summary describes a simple mechanical device for accessing medication vials and does not mention any AI or ML components or functionalities.
No
The device is a vial adapter for medication transfer, not a device directly used for therapy. Its function is to facilitate the access and transfer of medications, which are then used for therapy.
No
The device is a vial adapter for transferring or withdrawing fluids from medication vials, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Sterile single use device," which indicates a physical, hardware component (a vial adapter). The intended use also describes a physical interaction with medication vials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "transfer or withdrawal of fluids from the vial" and "facilitating the withdrawal or addition of drugs/solutions from or to the vial." This describes a device used in the preparation and administration of medications, not for testing biological samples to diagnose or monitor a medical condition.
- Device Description: The description "Sterile single use device" is consistent with a medical device used for fluid transfer, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
- Using reagents or assays
The device is a vial adapter, which is a type of medical device used in the preparation and administration of medications. It facilitates access to medication vials in a needleless manner.
N/A
Intended Use / Indications for Use
Robertsite* Vial Adapter is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
Product codes
LHI
Device Description
Sterile single use device.
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
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)
Testing was performed using the FDA's Draft October 12, 2000 "Guidance on 510(k) submissions for Intravascular Administration Sets" and in house protocol performance data gathered in design verification and validation testing demonstrated that the Robertsite* Vial Adapter is substantially equivalent to the predicate Alaris Smartsite® Needle-free Vial Access Device and for met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
Clinical performance testing was not required.
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
MAR 2 3 2004
APPENDIX 6
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A. Submitter Information:
Submitter Name: Address:
Telephone Number: Fax Number: Contact Person: Date of Preparation
- B. Device Name: Trade Name: Common/Usual Name: Classification Name:
- C. Predicate Device Name: Trade Name: Predicate Device name: Trade Name:
Halkey-Roberts Corporation 11600 M. L. King Blvd., North St. Petersburg, FL 33716 727-577-1300 727-578-0450 John Sheldon January 14, 2004
Robertsite* Vial Adapter Robertsite* Vial Adapter Medication Vial Adapter Intravascular Administration Set Accessory
Robertsite* Needleless Injection site Swabable Luer Valve Alaris Smartsite® Needle-free Vial Access Device Vial Adapter with Smartsite®
D. Device Description:
Sterile single use device.
E. Intended Use:
Robertsite* Vial Adapter is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
F. Technological Characteristics Summary
1. Does the new device have the same indication statements?
Yes. The Robertsite* Vial Adapter has the same indication for use as the Alaris Smartsite® Needle Free Vial Access device. Both vial adapter systems are indicated for multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
2. Does the new device have the same technological characteristics, e.g. Design, Materials, etc?
No. The stem and cap configuration of the Robertsite* Vial Adapter is different from that of the Alaris Smartsite® Needle-free Vial Access Device in the length of the device and the configuration of the split septum. The principles of operation are unchanged from the predicate comparison device.
1
3. Could the new characteristics affect safety or effectiveness?
Yes.
4. Do the new characteristics raise new types of safety or effectiveness questions?
No. The safety and effectiveness questions are the same for all vial adapter systems.
5. Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The FDA's Draft October 12, 2000 "Guidance on 510(k) Submissions for Intravascular Administration Sets" and in house tests protocols were used to evaluate the device's performance.
6. Are performance data available to assess effects of new characteristics?
Yes.
7. Do performance data demonstrate equivalence?
Yes.
Based on FDA's decision tree, the Robertsite* Vial Adapter is substantially equivalent to the comparison predicate device, the Alaris Smartsite® Needle-free Vial Access Device system cleared for market on November 13, 2001 (K013087).
ાન. Performance Data
Testing was performed using the FDA's Draft October 12, 2000 "Guidance on 510(k) submissions for Intravascular Administration Sets" and in house protocol performance data gathered in design verification and validation testing demonstrated that the Robertsite* Vial Adapter is substantially equivalent to the predicate Alaris Smartsite® Needle-free Vial Access Device and for met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
l. Clinical Performance Testing
Clinical performance testing was not required.
J. Conclusion
The Robertsite* Vial Adapter meets all the acceptance criteria of the testing performed and, based on FDA's decision tree, the Robertsite* Vial Adapter is substantially equivalent to the predicate device, the Alaris Smartsite® Needle-free Vial Access Device cleared for market on November 13, 2001 (K013087).
۰۰ ۰۰
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Halkey-Roberts Corporation C/O Ms. Susan Grill Responsible Third Party Official Underwriter Laboratories. Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709
Re: K040634
Trade/Device Name: Robertsite* Vial Adapter Model 245700021 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 8, 2004 Received: March 10, 2004
Dear Ms. Grill:
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.
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Page 2 - Ms. Gill
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); 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). please contact the Office of Compliance at (301) 594-5618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clare
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko40634
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indications for Use:
Robertsite* Vial Adapter
Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
(Please do not write below this line -continue on another page if needed)
Concurrence of Office of Device Evaluation
Prescription Use كار (Per 21 CFR 801.109)
OR
Over - The - Counter Use _____________________________________________________________________________________________________________________________________________________
Anton Dinar
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040634