(180 days)
No
The 510(k) summary describes a mechanical adapter for connecting catheters to infusion devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on mechanical and fluid dynamics properties.
No.
The device facilitates the delivery of substances (anesthetics) through a catheter system but does not directly administer therapy itself; it is an accessory to infusion devices and catheters used for pain management.
No
The device is an adapter intended to facilitate the delivery of substances through a catheter system for anesthesia or analgesia, not to diagnose a medical condition.
No
The device description clearly describes a physical adapter that connects a catheter to an infusion device, including different versions with and without electrical connectors. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate access to a catheter for the delivery of substances (anesthetic or analgesic) into a patient's body. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a connecting link between a catheter and an infusion device, designed to deliver substances into the patient.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used to access anatomical sites within the body (epidural space, nerves) for direct administration of substances.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device's function is entirely focused on delivering substances into the body.
N/A
Intended Use / Indications for Use
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Product codes (comma separated list FDA assigned to the subject device)
CAZ, BSO
Device Description
The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space, nerves and nerve plexuses (upper extremity, lower extremity, abdominal and paravertebral locations)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital and sub-acute facility environment as directed by a physician.
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)
Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs. All samples passed the established acceptance criteria. The results concluded that the SnapLock Adapter has successfully passed all functional requirements to establish product safety and effectiveness for its intended use.
Summary of tests performed and results:
- Cytotoxicity - L929 MEM Elution Assay: Acceptable
- Sensitization - Kligman Maximization Assay: Acceptable
- Irritation - Intracutaneous Injection Assay: Acceptable
- Acute Systemic Toxicity - Systemic Injection Test: Acceptable
- Acute Systemic Toxicity - Material Mediated Test: Acceptable
- Hemocompatibility - Rabbit Blood Hemolysis (Complete) ASTM Test: Acceptable
- Genotoxicity - Mouse Lymphoma Mutagenesis Assay: Acceptable
- Genotoxicity - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay with Confirmation – ISO: Acceptable
- Subacute Systemic Toxicity Test: Acceptable
- Closing Force – SnapLock Adapter to Catheter body: Pass (No greater than 17lb force (75N) to close for 19Ga or 20Ga catheter; No greater than 12lb force (53.8N) for Next Gen SnapLock)
- Opening Force – SnapLock Adapter to Catheter Body: Pass (Minimum 10lb force (44.48N) required to cause retaining tab to fail)
- Component Compatibility/Interaction: Pass (Allow easy insertion of mating catheter)
- Tensile Force – SnapLock Adapter to Catheter Body: Pass (>= 5N (1.12lbf) at failure)
- Leakage – SnapLock adapter to catheter body: Pass (No leak when pressurized to 25 psi (172 kPa) for 30 seconds in a closed system)
- Occlusion – SnapLock Adapter to Catheter Body: Pass (Shall not occlude catheter)
- Spontaneous Partial Opening Test: Pass (Must remain closed for 72 hours with retaining tab in place after full closure)
- Flow Rate – Continuous Flow SnapLock: Pass (Minimum 60mL/hour (1mL/min) when tested by deionized or distilled water under 69 kPa (10psi))
- Flow Rate - Single Shot or Bolus: Pass (Minimum 3.47 mL/min when tested with 20mL syringe using deionized or distilled water)
- Aspiration: Pass (Fluid presence shall be visually verified)
- Leakage, Maximum Duration at Continuous Pressure: Pass (Shall not leak over 72 hours when continuous pressure is 1 psi)
- Weld Force: Pass (Minimum 20lb force (88.96N) required to cause weld joint to fail)
- Conical Fittings: Pass (Comply with BS 6196 or AAMI/CN6:2016 (ISO 80369-6))
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.
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
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Kristen Bisanz Regulatory Affairs Team Lead 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560
Re: K230603
Trade/Device Name: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ, BSO Dated: July 27, 2023 Received: August 1, 2023
Dear Kristen Bisanz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230603
Device Name
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnaoLock Adapter (Luer Connection) (CA-00010-19): Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Comection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Indications for Use (Describe)
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY Arrow SnapLock Catheter Adapter K230603
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 404.290.9807 919.433.4996 Fax:
Contact Person
Kristen Bisanz Kristen.bisanz@teleflex.com Regulatory Affairs Team Lead
Date Prepared
August 14, 2023
Device Name
| Trade Name: | Arrow SnapLock Catheter Adapter |
|---|---|
| Classification Name: | Anesthesia Conduction Kit |
| Product Code: | CAZ, BSO |
| Regulation Number: | 868.5140 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
Device Models
K-05520-005C Arrow Non-Stimulating SnapLock Adapter CA-000010-19 Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) CA-000014-19 Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) TZ-02060-001 Arrow Stimulating SnapLock Adapter (with cable) TZ-05000-002 Arrow Stimulating SnapLock Adapter (with tab)
Predicate Device
The primary predicate device for this submission was cleared in K103658 on May 16, 2012. The reference predicate device for this submission was cleared in K1220247 on Aug 28, 2012.
Device Description
4
The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
| Product
Code | Product Code
Description | Representative Photo | Description |
|------------------|-------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| K-05520-
005C | Arrow Non-Stimulating
SnapLock Adapter | Image: blue and black adapter | The non-Stimulating
SnapLock contains no
elecrical connectors
and is used with
epidural and
peripheral nerve block
catheters. |
| CA-000010-
19 | Arrow Next Generation
Non-Stimulating
SnapLock Adapter (Luer
Adapter) | Image: blue and yellow adapter | The Next Generation
SnapLock features a
snap-of-center style
closing mechanism. |
| CA-000014-
19 | Arrow Next Generation
Non-Stimulating
SnapLock Adapter
(Neuraxial Adapter) | Image: blue and yellow adapter | The Next Generation
SnapLock features a
snap-of-center style
closing mechanism. |
| TZ-02060-
001 | Arrow Stimulating
SnapLock Adapter (with
cable) | Image: blue adapter with cable | The Simulating
SnapLock is designed
for use with the
StimuCath Peripheral
Nerve Block Catheter. |
| TZ-05000-
002 | Arrow Stimulating
SnapLock Adapter (with
electrical connector tab) | Image: blue adapter with electrical connector | An electrical current
can be conducted
through the connector. |
5
Indications for Use
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Management Catheter IFU for complete catheter instructions for use.
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The Arrow FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Patient Population
This device is for adult patients requiring administration of local anesthetics for up to 72 hours.
Environment of use
The device is to be used in a hospital and sub-acute facility environment as directed by a physician.
Contraindications
There are no known contraindications for this device.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) Number | Date Cleared |
|---|---|---|---|
| SnapLock Adapter (component of | |||
| FlexTip Plus Epidural Catheter Kit) | Arrow | K103658 | May 3, 2012 |
| Reference Device : SnapLock | |||
| Adapter (component of StimuCath | |||
| PNB Catheter Kit) | Arrow | K122027 | Aug 28, 2012 |
Comparison to Predicate Device
The proposed device has similar or equivalent indications for use, operating principles, classification, sterilization and general design as the predicate device. Biocompatibility testing and performance testing has been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes discussed above do not impact the safety or effectiveness of the SnapLock Catheter Adapter. The subject device is therefore substantially equivalent to the predicate device identified within this submission.
6
| | Primary Predicate
K103658
SnapLock Adapter
(component of
FlexTip Plus
Epidural Catheter
Kit) | Reference Predicate
K122027
SnapLock Adapter
(component of
FlexBlock
Peripheral Nerve
Block Kit) | Proposed
SnapLock
Catheter Adapter | Equivalenc
e |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Classification
Name | Anesthesia Conduction
Kit and Catheter,
Conduction, Anesthetic | Anesthesia Conduction
Kit and Catheter,
Conduction, Anesthetic | Anesthesia
Conduction Kit | Identical |
| Device Name | SnapLock Adapter
(component of FlexTip
Plus Epidural Catheter
Kit) | SnapLock Adapter
(component of
FlexBlock Peripheral
Nerve Block Kit) | Arrow SnapLock
Catheter Adapter | Identical |
| Common Name | Catheter Adapter | Catheter Adapter | Catheter Adapter | Identical |
| Product Code | 73CAZ (primary)
and
73BSO (secondary) | 73CAZ (primary)
and
73BSO (secondary) | 73CAZ (primary) | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Regulation
Number | 868.5140 | 868.5140 | 868.5140 | Identical |
| Indications for
Use | The Arrow Epidural
Catheter permits
access to the epidural
space for the
administration of
epidural anesthetic.
The epidural catheter
is intended for use up
to 72 hours. | The Arrow
FlexBlock
Continuous
Peripheral Nerve
Block Kit/Set
permits
placement of
catheters next to
nerves and nerve
plexuses for
continuous nerve
block anesthesia
or analgesia
techniques
including upper | SnapLock
Catheter/Syringe
Adapter is intended
to be used in
conjunction with 19
and 20 Ga. Arrow
Pain Management
Catheters to
facilitate access to
the catheter so that
an infusion device
may be used. Please
refer to applicable
Arrow Pain
Manager Catheter | Identical |
| | | extremity, lower
extremity,
abdominal and
paravertebral
locations of the
adult and
pediatric patient
for periods not
exceeding 72
hours. | IFU for complete
catheter instructions
for use.
The Arrow Epidural
Catheter permits
access to the
epidural space for
the administration
of epidural
anesthetic. The
epidural catheter is
intended for use up
to 72 hours. | |
| Prescription | Yes | Yes | Yes | Identical |
| Environment of
Use | Hospitals, Sub-acute
facilities, and
emergency medical
services | Hospitals, Sub-acute
facilities, and
emergency medical
services | The device is to be
used in a hospital
and sub-acute
facility
environment as
directed by a
physician. | Identical |
| Patient
Population | Patients requiring
administration of
local anesthetics for
up to 72 hours | Patients requiring
administration of
local anesthetics for
up to 72 hours | Patients requiring
administration of
local anesthetics for
up to 72 hours | Identical |
| Contraindicatio
ns | None for stand-alone
SnapLock | None for stand-alone
SnapLock | None for stand-
alone SnapLock | Identical |
| Shelf Life | Two (2) years from
date of manufacture | Two (2) years from
date of manufacture | Two (2) years from
date of manufacture | Identical |
| Tensile
Strength | The joint tensile
force between the
SnapLock Adapter
and catheter shall be
5N or greater, when
tested in accordance
with BS 6196 | The joint tensile
force between the
SnapLock Adapter
and catheter shall be
5N or greater, when
tested in accordance
with BS 6196 | The joint tensile
force between the
SnapLock Adapter
and catheter shall
be 5N or greater
when tested in
accordance with BS
6196 | Identical |
| Flow Rate | The SnapLock shall
have a minimum
flow rate of 10cc
water per minute at
30psi. | The SnapLock shall
have a minimum
flow rate of 10cc
water per minute at
30psi. | The catheter flow
capacity shall be
higher than
60mL/hour when
tested by distilled
water under
pressure of 10psi | Equivalent,
see
substantial
equivalence
section |
| Leakage | There shall be no
evidence of water
leakage on the
SnapLock surface | There shall be no
evidence of water
leakage on the
SnapLock surface | Shall not have a
leak sufficient to
form a falling drop | Equivalent,
see
substantial
equivalence |
| | when subjected to
15psi water for 30
seconds. | SnapLock surface
when subjected to
15psi water for 30
seconds. | when pressurized to
25psi (172 kPa) for
30 seconds | section |
| Sterilization | The sterility
assurance level of the
device is 10-6. | The sterility
assurance level of the
device is 10-6. | The sterility
assurance level of
the device is 10-6. | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Identical |
| Materials | Polycarbonate, Resin,
Delrin, Polyethylene | Polycarbonate, Resin,
Delrin, Polyethylene | Polycarbonate,
Resin, Delrin,
Polyethylene | Equivalent,
see
substantial
equivalence
section |
7
8
Substantial Equivalence Discussion:
Flow Rate: The flow rate for the proposed SnapLock reflects an updated acceptance criteria which more accurately reflects what is seen in the clinical setting. Additional details and testing are included in the Performance Testing section. Due to the updated testing and clinical rationale, the acceptance criteria for the flow rate is equivalent to the predicate acceptance criteria.
Leakage: The acceptance criteria for the proposed SnapLock Adapter leakage test is more stringent than the predicate. The leakage tests the maximum duration usage of the SnapLock to ensure leakage will not occur. Due to this, the acceptance criteria for the leakage test is equivalent to the predicate acceptance criteria.
Materials: The proposed SnapLock Adapter contains a new resin for the extrusion tubing. Additionally, the Next Gen SnapLock Adapter contains an updated design of the slider as compared to the predicate. The slider helps to secure the catheter tightly and prevent disconnection during use. Comprehensive functional testing has been successfully completed on the SnapLock Adapter. The functional testing proves the proposed device meets the standard requirements and performs as well as the predicate device. Biocompatibility testing has been performed on the final finished proposed device. The materials tested all met the ISO 10993 requirements. There is no difference between the subject and predicate with respect to indications for use or technology
Materials and Biocompatibility Testing
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. The SnapLock device is classified as an external communicating device with tissue/bone/dentin contact for a prolong duration.
9
Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - L929 | ||
| MEM Elution Assay | The test article will meet the requirements of the | |
| test if it obtains a Grade of 0,1,or 2 (not more | ||
| than 50% of the cells are round, devoid of | ||
| intracytoplasmic granules, and no extensive cell | ||
| lysis) | Acceptable | |
| Sensitization - | ||
| Kligman | ||
| Maximization Assay | The test article will be considered a non-irritant | |
| if the difference between the test article mean | ||
| score and the vehicle control mean score is 1.0 | ||
| or less. | Acceptable | |
| Irritation - | ||
| Intracutaneous | ||
| Injection Assay | The test article will meet the requirements of the | |
| test if it receives a Grade of 1, 0 or less using the | ||
| Kligman scoring system. | Acceptable | |
| Acute Systemic | ||
| Toxicity - Systemic | ||
| Injection Test | The test article will meet the requirements of the | |
| test if it does not induce a significantly greater | ||
| biological reaction than the control. | Acceptable | |
| Acute Systemic | ||
| Toxicity - Material | ||
| Mediated Test | The test article will meet the requirements of the | |
| test if no rabbit shows an individual rise in | ||
| temperature of 0.5°C or more above the baseline | ||
| temperature. | Acceptable | |
| Hemocompatibility - | ||
| Rabbit Blood | ||
| Hemolysis | ||
| (Complete) ASTM | ||
| Test | The test article will meet the requirements of the | |
| test and is not considered to have hemolytic | ||
| activity potential, if the hemolytic index above | ||
| the negative control article and negative control | ||
| article extract is |