(57 days)
The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies.
The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.
The Single Dose Dispensing Pin (Dispensing Pin) is a stand-alone, single use, disposable syringe access device which permits access to a medication vial without the use of a needle. The Dispensing Pin is connected to a needleless syringe and is inserted into the rubber stopper of a medication vial. The healthcare provider uses the Dispensing Pin to inject or withdraw fluid from a vial.
The provided text describes a medical device, the "Single Dose Dispensing Pin," and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) summary for premarket notification to the FDA. In this type of submission, the focus is on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices, rather than conducting new performance studies against pre-defined acceptance criteria for a novel device.
Here's how the information provided aligns with your request, with critical missing details highlighted:
Description of Acceptance Criteria and Study to Prove Device Meets Them
Missing Information: The provided text explicitly states: "The performance data supplied in this submission indicate that the Single Dose Dispensing Pin meets all specified requirements, and is substantially equivalent to the predicate devices." However, it does not explicitly list the "specified requirements" (acceptance criteria) or describe the actual "performance data" or studies conducted.
Without the actual study report or a more detailed summary of its findings, it's impossible to fill out most of the requested table and answer the specific study-related questions.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, this table cannot be completed. The document only generally states that the device "meets all specified requirements" without detailing those requirements or the specific performance metrics achieved.
| Acceptance Criteria (e.g., specific thresholds for flow rate, leak integrity, compatibility) | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe a "test set" in the context of performance testing, nor does it provide any sample size or data provenance details. The 510(k) is about demonstrating substantial equivalence, not a new performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This question is not applicable to the information provided. There is no mention of "ground truth" or expert review in the context of a performance study for this device in the given text.
4. Adjudication method for the test set
Missing Information: Not applicable. No test set or adjudication method is described.
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
Missing Information: This question is not applicable. The device is a "Single Dose Dispensing Pin," which is a physical medical device, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing Information: Not applicable. No "ground truth" is discussed in relation to a performance study for this device.
8. The sample size for the training set
Missing Information: This question is not applicable. The device is a physical medical device and does not involve AI or machine learning models that would require a "training set."
9. How the ground truth for the training set was established
Missing Information: This question is not applicable. As above, there's no training set for this type of device.
In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing predicate devices. It states that performance data was supplied and that the device meets requirements, but it does not provide the details of those performance requirements (acceptance criteria), the actual performance data, or the methodology of any studies conducted. Therefore, most of the specific questions about acceptance criteria and study details cannot be answered from the given text.
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SUMMARY OF SAFETY AND EFFECTIVENESS Single Dose Dispensing Pin
SUBMITTER INFORMATION
| A. | Company Name: | ALARIS Medical Systems, Inc. |
|---|---|---|
| B. | Company Address: | 10221 Wateridge CircleSan Diego, CA 92121-2772 |
| C. | Company Phone:Company Fax: | (858) 458-7563(858) 458-6223 |
| D. | Contact Person: | Renée L. FluetPrincipal Regulatory Affairs SpecialistALARIS Medical Systems, Inc. |
| E. | Date Summary Prepared: | September 14, 2001 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Set, Intravascular Administration |
|---|---|---|
| B. | Trade/Proprietary Name: | Single Dose Dispensing Pin |
| C. | Classification: | 21 CFR 880.5440, Class II |
| D. | Product Code: | LHI, I.V. Fluid Transfer Set |
DEVICE DESCRIPTION
The Single Dose Dispensing Pin (Dispensing Pin) is a stand-alone, single use, disposable syringe access device which permits access to a medication vial without the use of a needle. The Dispensing Pin is connected to a needleless syringe and is inserted into the rubber stopper of a medication vial. The healthcare provider uses the Dispensing Pin to inject or withdraw fluid from a vial.
SUBSTANTIAL EQUIVALENCE
The Single Dose Dispensing Pin as manufactured is of comparable type and is substantially equivalent to the following predicate devices:
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued Single Dose Dispensing Pin
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Micro Pin, MP-1000 | B. Braun of America, Inc. | K790472 | 03/26/1979 |
| One Time Vial AccessSpike | ICU Medical, Inc. | K934561 | 02/10/1994 |
INTENDED USE
The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies.
The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.
TECHNOLOGICAL CHARACTERISTICS
The Single Dose Dispensing Pin has the same technological characteristics as the predicate devices; the B. Braun Micro Pin (K790472) and the ICU Medical One Time Vial Access Spike (K934561). The devices consist of similar components made of the same type of materials using the same method of manufacture. The associated applications and intended use of the devices are the same. Since there are no technological differences, there are no new questions of safety and effectiveness.
PERFORMANCE DATA
The performance data supplied in this submission indicate that the Single Dose Dispensing Pin meets all specified requirements, and is substantially equivalent to the predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Ms. Renee L. Fluet Principal Regulatory Affairs Specialist Alaris Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733
Re: K013087
Trade/Device Name: Single Dose Dispensing Pin, Model 2201 Regulation Number: 880.5440 Regulation Name: Set, Intravascular Administration (I.V.) Fluid Transfer Set Regulatory Class: II Product Code: LHI Dated: September 12, 2001 Received: September 17, 2001
Dear Ms. Fluet:
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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
INDICATIONS FOR USE NOV 1 3 2001
510(k) Number: Device Trade Name: KO1 3087 ______________ (To Be Assigned By FDA)
Single Dose Dispensing Pin
Indications For Use:
The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies.
The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
falticien Cueraitz
·vision of Dental, Infection Control, C General Hospital Devi 110(k) Number _
9/14/01 0027
Confidential
§ 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.