(398 days)
Not Found
No
The device description and intended use focus solely on the mechanical function of fluid transfer and reconstitution. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The Smart-Rod™ is described as a "single use reconstitution device" intended for the transfer of a diluent to a vial and the return transfer of an admixture to a syringe. It facilitates the preparation of a drug but does not directly provide therapy.
No
The device is described as a "single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe." It facilitates the preparation of medication for injection, not the diagnosis of a condition.
No
The device description clearly states it is a "single-use reconstitution device consisting of a preassembled vial socket and plunger rod," which are physical hardware components.
Based on the provided information, the Smart-Rod™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the reconstitution of a drug product by transferring a diluent from a syringe to a vial and then transferring the admixture back to the syringe. This is a process related to preparing a medication for administration, not for performing a diagnostic test on a sample from the human body.
- Device Description: The device is described as a "single-use reconstitution device" that facilitates the transfer of fluids between a syringe and a vial. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
The Smart-Rod™ is a medical device used in the preparation of medication for injection, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe.
The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Smart-Rod™ is a single-use reconstitution device consisting of a preassembled vial socket and plunger rod. The Smart-Rod™ is designed to be used together with a pre-filled syringe. The pre-filled syringe would be legally authorized through its own clearance or customer New Drug Application and is not intended to be cleared as part of this premarket notification. The Smart-Rod™ plunger rod replaces the usual plunger rod of the pre-filled syringe and has an integral needle designed to perforate the plunger of the pre-filled syringe for fluid transfer from the syringe to the drug vial (connected using the vial socket) through the internal fluid path in the rod. Once reconstitution is complete, the device permits the transfer of the reconstituted drug product back to the The integral needle is retracted into the plunger rod by unscrewing the syringe. The vial socket and vial are discarded, and the filled syringe vial socket. containing reconstituted drug is ready for use and the drug product may be injected by means of the yet unexposed needle equipping the syringe.
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
physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.
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)
16 qualification tests were conducted to demonstrate the operational performance of the device, including attachment to vial and syringe, interaction with the vial stopper and the syringe plunger, operational performance and integrity during use.
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.
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
§ 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
510(k) SUMMARY 5.
K070.584
APR - 2 2008
| Submitter's Name: | Duoject Medical Systems Inc. |
|---|---|
| Address: | 50 chemin de Gaspe, Complex B-5 |
| Bromont, Quebec | |
| Canada J2L 2N8 | |
| Telephone: | (450) 534-3666 ext.24 |
| Fax: | (450) 534-3700 |
| Contact Person: | Maud Richard |
| Date of Summary: | April 1, 2008 |
| Trade Name: | Smart-Rod™ Reconstitution System |
| Common Name: | Reconstitution system |
| Classification Name: | Fluid Transfer Set (includes vial adapter) per 21 CFR |
| 880.5440 | |
| Predicate Device: | Clip'n'Ject® Reconstitution System (K041691) |
| Bioject® Needle-Free Vial Adapter (K963012 & | |
| K043304) |
Device Description:
The Smart-Rod™ is a single-use reconstitution device consisting of a preassembled vial socket and plunger rod. The Smart-Rod™ is designed to be used together with a pre-filled syringe. The pre-filled syringe would be legally authorized through its own clearance or customer New Drug Application and is not intended to be cleared as part of this premarket notification. The Smart-Rod™ plunger rod replaces the usual plunger rod of the pre-filled syringe and has an integral needle designed to perforate the plunger of the pre-filled syringe for fluid transfer from the syringe to the drug vial (connected using the vial socket) through the internal fluid path in the rod. Once reconstitution is complete, the device permits the transfer of the reconstituted drug product back to the The integral needle is retracted into the plunger rod by unscrewing the syringe. The vial socket and vial are discarded, and the filled syringe vial socket. containing reconstituted drug is ready for use and the drug product may be injected by means of the yet unexposed needle equipping the syringe.
pg 1 + 2
1
Intended Use:
The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe.
The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.
Substantial Equivalence:
The Smart-Rod™ has the same intended use as the predicate devices, with the primary purpose of permitting the transfer of a diluent contained in a syringe to a vial containing a drug product, in order to allow drug reconstitution prior to injection. All devices are single-use and intended to be marketed sterile in individual packaging.
It combines design concepts found in the predicate devices for vial attachment, vial closure piercing and use of the syringe plunger to open a fluid path.
The Smart-Rod™ device is similar in design to Bioject®'s Needle-Free Vial Adapter and West's Clip'n'iect® with respect to the mechanism of attachment to a vial. Its vial closure piercing mechanism is identical to that of Bioject®'s Needle-free Vial Adapter, however unlike the Bioject® Needle-Free vial adapter, the Smart-Rod™ is intended for use with a syringe equipped with a needle, like the West Clip'n'ject® device.
Construction materials include polycarbonate, polyethylene, ABS and steel. Predicate devices use polycarbonate, polyethylene and steel in the operation of the device. ABS is a well established material for other devices of similar intended use.
Performance testing:
16 qualification tests were conducted to demonstrate the operational performance of the device, including attachment to vial and syringe, interaction with the vial stopper and the syringe plunger, operational performance and integrity during use.
070584 pg 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2008
Ms. Maud Richard Compliance Engineer Duoject Medical Systems, Incorporated 50 rue de Gaspe, Complex B-5 Bromont, (Quebec) CANADA J2L 2N8
Re: K070584
Trade/Device Name: Smart-Rod Reconstitution System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 12, 2008 Received: March 17, 2008
Dear Ms. Richard:
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.
3
Page 2 - Ms. Richard
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours.
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
4. INDICATIONS FOR USE STATEMENT - -------------------------------------------------------------------------------------------------------------------------------------------
510(k) Number (if known): K070584 Device Name: Smart-Rod™
Indications for Use:
The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe.
The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number: 1 1