(63 days)
Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
The Integra® Miltex® N-Traligamentary Syringe is a cartridge syringe intended to inject anesthetic agents into the intraligamentary space (i.e., periodontal ligament). The device consists of a stainless steel syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the barrel cap, the device is used to administer an injection to the patient. The Integra® Miltex® N-Tralig® Intraligamentary Syringe delivers 0.2cc of anesthetic with each ratchet. The ratchet action of the syringe allows for the slow infiltration of anesthetic during the Periodontal Ligament Injection (PDL injection) to help minimize patient discomfort. The 30° adapter helps provide a better angle with difficult-to-reach injections. The syringe comes with a solid barrel and a window barrel.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Based on the provided text, the device is the Integra® Miltex® N-Tralig® Intraligamentary Syringe. This document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics and acceptance criteria as might be found in a De Novo or PMA submission.
Therefore, the "acceptance criteria" discussed here are primarily related to meeting recognized standards and validating specific processes, rather than performance metrics of an AI algorithm or a clinical effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a medical device like a syringe, the "acceptance criteria" are typically related to standards compliance and validation of operational aspects (like cleaning and sterilization) rather than clinical performance metrics in the way one might evaluate an AI algorithm's diagnostic accuracy.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Results) |
|---|---|
| AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing | Compliant (implied by "Pass" results) |
| AAMI TIR30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices | Compliant (implied by "Pass" results) |
| ANSI/AAMI/ISO 17665-1:2006/(R)2013 (EN ISO 17665-1:2006) – Sterilization of health care products - Moist heat | Compliant (implied by "Pass" results) |
| ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012/A4:2013 Comprehensive guide to steam sterilization and sterility assurance | Compliant (implied by "Pass" results) |
| ANSI/AAMI ST81:2004/(R)2010 – Sterilization of medical devices - Information to be provided by the manufacturer | Compliant (implied by "Pass" results) |
| ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer | Compliant (implied by "Pass" results) |
| ISO 14971 - Medical devices - Application of risk management to medical devices | Compliant (implied by "Pass" results) |
| ISO 7153-1 – Surgical instruments -- Metallic materials -- Part 1: Stainless steel | Compliant (Material selection) |
| ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | Compliant (Material selection) |
| Manual Cleaning Validation | Pass |
| Pulse pre-vacuum sterilization validation at 132°C for 4 minutes | Pass |
| Pulse pre-vacuum sterilization validation at 134°C for 3 minutes | Pass |
| Gravity Displacement Steam Sterilization Validation at 132°C for 15 minutes | Pass |
2. Sample size used for the test set and the data provenance
The document describes non-clinical technical testing (cleaning, sterilization validation). It does not mention a "test set" in the context of patient data or clinical performance. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical syringe, not an AI diagnostic tool. Ground truth in the context described (cleaning and sterilization validation) would be established by the adherence to specified quality and safety standards and documented validation protocols, likely involving lab technicians and engineers, not clinical experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical "test set" or diagnostic evaluation that would require an adjudication method.
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
Not applicable. This is a medical device (syringe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (syringe), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical tests (cleaning and sterilization validation), the "ground truth" is adherence to established, recognized international and national standards (e.g., ISO, AAMI). For biocompatibility, the ground truth is based on the long-standing safety record and material specifications of stainless steel.
8. The sample size for the training set
Not applicable. This is a medical device (syringe), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
Integra LifeSciences Corporation Ms. Ruthanne Vendy Regulatory Affairs Manager 589 Davies Drive York, PA 17402
Re: K142414
Trade/Device Name: Miltex® N-Tralig® Intraligamentary Syringe Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: September 30, 2014 Received: October 2, 2014
Dear Ms. Vendy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Vendy
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K142414
Integra® Miltex® N-Tralig® Intraligamentary Syringe Device Name:
Indications for Use:
Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
√ Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 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)
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K142414
510(k) Summary
| Submitted by: | Integra York PA, Inc.589 Davies DriveYork, PA 17402 USA |
|---|---|
| Contact Person: | Ruthanne VendyRegulatory Affairs ManagerIntegra York PA, Inc.589 Davies Drive, York, PA 17402 USAPhone: (717) 757-7974 |
| Date Prepared: | September 30, 2014 |
| Device Trade Name: | Integra® Miltex® N-Tralig® Intraligamentary Syringe |
| Brands: | Miltex® |
| Device Common Name: | Intraligamentary Syringe |
| Classification Name: | Syringe, Cartridge |
| Class: | Class II |
| Product Code: | EJI |
| CFR Classification: | 21 CFR 872.6770 |
| Predicate Device: | Intralig Intraligamentary Syringe (K823536)This predicate device has not been subject to a design-related recall |
Device Description:
The Integra® Miltex® N-Traligamentary Syringe is a cartridge syringe intended to inject anesthetic agents into the intraligamentary space (i.e., periodontal ligament). The device consists of a stainless steel syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the barrel cap, the device is used to administer an injection to the patient.
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The Integra® Miltex® N-Tralig® Intraligamentary Syringe delivers 0.2cc of anesthetic with each ratchet. The ratchet action of the syringe allows for the slow infiltration of anesthetic during the Periodontal Ligament Injection (PDL injection) to help minimize patient discomfort. The 30° adapter helps provide a better angle with difficult-to-reach injections. The syringe comes with a solid barrel and a window barrel.
Indications for Use:
Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
Predicate Device Comparison:
The predicate device is the Intraligamentary Syringe (K823536). The below table provides a characteristic comparison of the N-Tralig compared to the predicate Intralig.
| Characteristic | New N-Tralig | K823536 Intralig | Comparison |
|---|---|---|---|
| Intended Use | Dental syringe used todeliver anesthetic. | Dental syringe used todeliver anesthetic. | Same |
| Indications for Use | Indicated to be used inconjunction withanesthetic needles andcartridges for injectionof anesthetic into theperiodontal ligament. | Indicated to be used inconjunction withanesthetic needles andcartridges for injectionof anesthetic into theperiodontal ligament. | Same |
| FDA Procode | 76EJI | 76EJI | Same |
| Operation | Injects a measured doseof 0.2 cc of anesthesiawith each squeeze of theinjection trigger | Injects a measured doseof 0.2 cc of anesthesiawith each squeeze of theinjection trigger | Same |
| CartridgeCompatibility | Designed for use withstandard anestheticcartridge | Designed for use withstandard anestheticcartridge | Same |
| Syringe type | Intraligamentary | Intraligamentary | Same |
| Anatomical use | Oral cavity | Oral cavity | Same |
| Sterility | Supplied non-sterile | Supplied non-sterile | Same |
| Ratcheting | single ratchet increment | multiple ratchetincrements | One actuation pertrigger pull |
| Syringe Body | Stainless steel | Chrome-plated brass | Material change |
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| Characteristic | New N-Tralig | K823536 Intralig | Comparison |
|---|---|---|---|
| Ball Bearing | Resin | Stainless steel | Material change |
| AdvancementBlock Spring | Located in rear ofadvancement block | Located in front ofadvancement block | Location ofadvancementblock spring |
| Trigger Handle | Concave | Convex | Trigger profile |
| Cleaning Methodfor this Device | Yes | N/A | Validated processby independenttesting lab |
| SterilizationMethod for thisDevice | Yes | N/A | Validated processby independenttesting lab |
There are no significant differences in technology, intended use, or design between the subject devices and the predicates selected.
Performance Standards:
One standard has been promulgated under Section 514 of the Food, Drug and Cosmetic Act for cartridge syringes: ISO 7405 Second edition 2008-12-15, dentistry - evaluation of biocompatibility of medical devices used in dentistry as published in the Federal Register (Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034; 01/30/2014).
The complete list of standards used to evaluate the Integra® Miltex® N-Tralig® Intraligamentary Syringe are as follows:
· AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
• AAMI TIR30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
• ANSVAAMI/ISO 17665-1:2006/(R)2013 (EN ISO 17665-1:2006) – Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices (FDA 14-261)
- ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012/A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities (FDA 14-439)
• ANSVAAMI ST81:2004/(R)2010 – Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (FDA 14-295)
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· ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
• ISO 14971 - Medical devices - Application of risk management to medical devices (FDA 5-40)
• ISO 7153-1 – Surgical instruments -- Metallic materials -- Part 1: Stainless steel (FDA 8-344)
· ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)] (FDA 4-212)
| Non-Clinical Testing Performed | Results |
|---|---|
| Manual Cleaning Validation | Pass |
| Pulse pre-vacuum sterilization validation at 132°C for 4 minutes | Pass |
| Pulse pre-vacuum sterilization validation at 134°C for 3 minutes | Pass |
| Gravity Displacement Steam Sterilization Validation at 132°C for 15 minutes | Pass |
No biocompatibility testing was performed on the proposed devices as 420, 303, and 301 stainless steels are recognized as suitable stainless steels for surgical instruments, parts, and assemblies per ISO 7153-1. Stainless steel has a long history of safe and effective use, and has been used in other medical devices that have been cleared by the FDA.
Conclusions drawn from Non-Clinical Data:
All necessary testing has been performed on the Integra® Miltex® N-Tralig® Intraligamentary Syringe and the results support the conclusion that the subject devices are substantially equivalent to the legally marketed predicate devices based on intended use, materials, technology, and design and as such, do not raise any concerns of safety or effectiveness.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.