(13 days)
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.
Sterile single use device.
The provided text describes a 510(k) premarket notification for a medical device called the "Robertsite* Vial Adapter." The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" cannot be fully extracted in the way it would for a typical performance study of AI/ML technologies. The document states that the new device has different characteristics (stem and cap configuration, length, split septum configuration) from the predicate device that could affect safety or effectiveness, but asserts that the safety and effectiveness questions are the same for all vial adapter systems.
The "acceptance criteria" referred to in this document are implicitly related to the "Guidance on 510(k) Submissions for Intravascular Administration Sets" and in-house protocols, rather than specific performance thresholds for metrics like accuracy or sensitivity.
Here's an attempt to answer your questions based on the provided text, acknowledging where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It generally states that "in house test protocols were used to evaluate the device's performance" and "performance data gathered in design verification and validation testing demonstrated that the Robertsite* Vial Adapter is substantially equivalent to the predicate... and for met predetermined acceptance criteria".
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "in house test protocols" and "design verification and validation testing," but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. The study is a laboratory-based performance testing of a medical device (vial adapter), not an AI/ML-based diagnostic system that relies on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. This is not a study involving human interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/ML-driven device, nor does it involve human readers in an interpretive capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML algorithm. The performance testing was of the physical device itself. The document states "Clinical performance testing was not required," indicating that the evaluation was based on laboratory testing of the device's physical characteristics and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI/ML or diagnostic studies is not directly applicable here. The "ground truth" for this device's performance would be the established scientific and engineering principles for fluid transfer, sterility, material compatibility, and structural integrity as outlined in the "FDA's Draft October 12, 2000 'Guidance on 510(k) Submissions for Intravascular Administration Sets'" and the manufacturer's in-house protocols. These would involve physical measurements, functional tests, and material analyses rather than expert consensus on images or pathology results.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device that requires a training set.
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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.
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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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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
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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
§ 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.