(89 days)
The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
The device comprises of the following components:
- Vial Adaptor System with 13 mm Vial converter
- Syringe Adaptor System
- Connecting Set
- Spike Port Adaptor
- Luer Lock Adaptor
The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic, sterile, pressure equalization within the vial, preventing drug particle and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required.
The Syringe Adaptor System is intended for connection to a standard luer lock syringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries.
The Spike Port Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.
The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end.
The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.
The provided text is a 510(k) summary for the TEVADAPTOR™, Closed Drug Reconstitution and Transfer System. It details the device's description, intended use, and its substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria, study methodologies, or performance metrics in the format requested (e.g., a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, or details on comparative effectiveness studies).
Such detailed information is typically found in the full submission documents, often referred to as validation or verification reports, which are not included in this publicly available 510(k) summary. The summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing the granular data of performance studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample sizes used for the test set and the data provenance: Not explicitly stated for performance testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for performance data is not detailed.
- Adjudication method: Not described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to this type of device (a drug reconstitution and transfer system) and not mentioned in the summary.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not specified for performance testing.
- The sample size for the training set: Not applicable and not mentioned.
- How the ground truth for the training set was established: Not applicable and not mentioned.
The document primarily states that the device "has equivalent performance characteristics" to its predicate device, the PhaSeal® closed system (K980381), and concludes that "The evaluation... does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices." This implies that the performance characteristics were deemed acceptable, likely based on similarity to the predicate and internal testing, but the specifics of how these were tested and what the acceptance criteria were are not detailed here.
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Image /page/0/Picture/1 description: The image shows the logos for Teva Medical Ltd. and nigada. The Teva Medical Ltd. logo is on the top and consists of the word "TEVA" in a boxy font, followed by the words "Medical Ltd." in a cursive font. The nigada logo is on the bottom and consists of the word "nigada" in a stylized font.
Image /page/0/Picture/2 description: The image shows a logo with the text "CERTIFIED QMS" in a circular arrangement around an oval shape. Inside the oval shape, the text "ISO 13485: 2003" is visible. Below the logo, the text "THE STANDARDS INSTITUTION OF ISRAEL" is printed. The logo appears to be a certification mark issued by The Standards Institution of Israel, indicating compliance with the ISO 13485:2003 standard for quality management systems.
SEP 2 4 2007
ת"מ
מודרקל
שמואל
מיגדה תעשיות ציוד רפואי
510(k) Summary:
TEVADAPTOR™, Closed Drug Reconstitution and Transfer System
Company Name: Migada Plant
Contact Person:
Yossi Shachar QA/RA Manager Telephone: +972-4-690-8826 +972-3-9267865 Fax: E-mail: yossi.shachar@teva.co.il
US Agent:
Mr. John Riggi Donawa Consulting 152 Schimwood Court Getzville, NY 14608 Phone: (716) 688 0543
Date prepared: June 10, 2007
Trade Name:
TEVADAPTOR™, Closed Drug Reconstitution and Transfer System
Common/usual name: Closed Drug reconstitution system
Classification name: Set, IV Fluid Transfer
5-2
A MEMBER OF T = I GROUP
שקבוצת
אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקם: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISRAEL TEL: (972)-4-6908800 FAX: (972)-9-8921665
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2.87
Image /page/1/Picture/1 description: The image shows the logos for "TEVA Medical ltd" and "nigada". The "TEVA" logo is in a bold, blocky font, while "Medical ltd" is in a cursive font. The "nigada" logo is in a stylized font that resembles a continuous line.
Image /page/1/Picture/2 description: The image is a black and white logo for The Standards Institution of Israel. The logo features a stylized triangle shape at the top, with the words "CERTIFIED QMS" arranged in an arc inside the triangle. Below this, there is a circle containing the text "ISO 13485: 2003". The words "THE STANDARDS INSTITUTION OF ISRAEL" are printed at the bottom of the logo.
Image /page/1/Picture/3 description: The image contains Hebrew text. The text appears to be a title or heading, possibly related to a document or book. The text is written in a traditional Hebrew font, and the letters are clearly visible. The text is "תשובות מודיקל"
מיגדה תעשיות ציוד רפואי
Product Code: LHI
Regulation No .: 880.5440
Class: II
Panel identification: General Hospital Panel
Predicate Device:
PhaSeal® closed system for the preparation and administration of parenteral drugs, Carmel Pharma AB, S-402 28 Gottingen, Sweden, cleared under 510(k) no. K980381.
Description of the device:
The device comprises of the following components:
- -Vial Adaptor System with 13 mm Vial converter
- ﻌ Syringe Adaptor System
- Connecting Set -
- Spike Port Adaptor -
- -Luer Lock Adaptor
The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic, sterile, pressure equalization within the vial, preventing drug particle and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required.
5-3
A MEMBER OF T = I GROUP
מקבוצת |
אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקס: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISRAEL TEL: (972)-4-6908800 FAX: (972)-9-8921665
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/(02/74)
3.f3
Image /page/2/Picture/1 description: The image shows the logos for Teva Medical and Nigada. The Teva Medical logo is on the top row, with the word "TEVA" in a boxy font and the words "Medical ltd." to the right of it in a cursive font. The Nigada logo is on the bottom row, with the word "nigada" in a stylized font.
Image /page/2/Picture/2 description: The image is a logo for the Standards Institution of Israel. The logo features a stylized triangle shape with the text "CERTIFIED QMS" and "ISO 13485: 2003" inside a circle. The text "THE STANDARDS INSTITUTION OF ISRAEL" is located at the bottom of the logo.
תע"מ מודיקל
מיגדה תעשיות ציוד רפואי
The Syringe Adaptor System is intended for connection to a standard luer lock syringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries.
The Spike Port Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.
The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end.
The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.
Intended Use:
The TEVADAPTORTM, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
Substantial Equivalence:
The TEVADAPTOR The, Closed Drug Reconstitution and Transfer System has the same intended use as the PhaSeal® closed system for the preparation and administration of parenteral drugs, cleared under 510(k) no. K980381 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.
Conclusion -
The evaluation of the TEVADAPTOR™, Closed Drug Reconstitution and Transfer System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.
2-4
A MEMBER OF T = // GROUP
ישי מקצוע
אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקס: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISRAEL TEL: (972)-4-6908800 FAX: (972)-9-8921665
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 2 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yossi Shachar Quality Assurance/Regulatory Affairs Manager Migada Plant North Industrial Zone P.O. Box 888 Kiryat Shmona, 10258 ISRAEL
Re: K071741
Trade/Device Name: TEVADAPTOR™, Closed Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5540 Regulation Name: Set, IV Fluid Transfer Regulatory Class: II Product Code: LHI Dated: June 25, 2007 Received: June 27, 2007
Dear Mr. Shachar:
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 - Mr. Shachar
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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clus
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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
TEVADAPTOR™, Closed Drug Reconstitution and Transfer System
Indications for Use:
The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
Prescription Use X OR (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
181
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE):
Antin V.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 15471941
4-2
§ 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.