(255 days)
Not Found
No
The device description and intended use clearly describe a physical needle for injection, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
Explanation: This device is a surgical tool used for injection, not a therapeutic device. Its purpose is to facilitate the delivery of medication for anesthesia rather than to treat a condition directly.
No
Explanation: The device is described as needles for injecting local anesthetics to provide regional anesthesia, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical components made of stainless steel, indicating it is a hardware device (needles) and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of local anesthetics into a patient to provide regional anesthesia. This is a direct medical intervention on a patient's body.
- Device Description: The description details a needle used for injection, a physical tool for delivering a substance into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples from the body. This device is used inside the body for a therapeutic purpose (delivering anesthetic).
N/A
Intended Use / Indications for Use
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia.
Product codes
BSP
Device Description
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.
Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.
A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.
The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.
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
Adult and child
Intended User / Care Setting
Not Found
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)
Nonclinical testing was conducted to ensure the safety and effectiveness of the subject device. The subject device passed all the testing and successfully demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
The study types include:
- Functional Performance: Stability test bonding to hub, Stability test bending rigidity, Penetration force and drag force for needles, Breakage test, Fluid leakage test, Separation axial load test, Separation unscrewing test, Overriding test, Stability test bonding to hub, Stability test bending rigidity.
- Packaging: Dye Penetration Test, Seal Strength, Transit Test.
- Sterility: China GB/T14233 2-2005 Test methods for medical infusions, blood transfusions and injection device - Part 2: Biological test methods.
- Residuals: Japan ISO10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, China EO: GB/T14233.1 Test methods for medical infusions, blood transfusions and injection device - Part 1: Chemical analysis method, ECH: ISO10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals.
- Sterilization: Bioburden (ISO11737-1).
- Biocompatibility: Cytotoxicity (ISO 10993-5), Intracutaneous Reactivity (ISO 10993-10), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Hemolytic (ISO 10993-4), Pyrogen (ISO 10993-11).
Key results: The subject device passed all the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2019
Dr. Japan Co., Ltd. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K183316
Trade/Device Name: Dr J Spinal and Epidural Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: July 8, 2019 Received: July 9, 2019
Dear Yolanda Smith:
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.
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
1
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,
Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K183316
Device Name Dr J Spinal and Epidural Needle
Indications for Use (Describe)
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia
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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Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
SPONSOR
| Company Name: | Dr. Japan Co., Ltd. |
|---|---|
| Company Address: | 1-1 Kagurazaka, Shinjuku-ku |
| Tokyo | |
| 162-0825 Japan | |
| Telephone: | 813-3513-8766 |
| Fax: | 813-3513-8226 |
| Contact Person: | Mitsuko Uchida |
| Summary Preparation Date: | August 2, 2019 |
DEVICE NAME
| Trade Name: | Dr. J Spinal and Epidural Needles |
|---|---|
| Common/Usual Name: | Spinal and Epidural Needles |
| Classification Name: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Regulation Number: | 21 CFR 868.5150 |
| Product Code: | BSP |
| Device Class: | Class II |
PREDICATE DEVICE
Legally marketed Equivalent Device
| Company | Product | 510(k) # |
|---|---|---|
| Myco Medical Supplies, Inc. | Dr. Japan's Phoenix Spinal & Epidural Needles | K990519 |
DEVICE DESCRIPTION
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.
Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.
A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.
The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.
4
DEVICE INDICATIONS FOR USE
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Dr. Japan Co., Ltd. is the manufacturer of the predicate device. This premarket notification represents a modification to the outer box only. The technological characteristics of the predicate device are not changed. The subject device is manufactured using the same inert, biocompatible material as the predicate device. In addition, bench testing was performed (see Section 18) to assure the performance and safety of subject device.
| Subject New Device | Predicate Device | Discussion | |
|---|---|---|---|
| Dr. J Spinal and Epidural Needles | Myco Medical Supplies, Inc. | ||
| K Number | K990519 | ||
| Manufacturer | Dr. Japan Co., Ltd. | ||
| Tianjin Hanaco Medical Co., Ltd. | Dr. Japan Co., Ltd. | ||
| Tianjin Hanaco Medical Co., | Same | ||
| Brand Name | Dr. J Spinal and Epidural Needles | Dr. Japan's Phoenix Spinal and | |
| Epidural Needles | |||
| Regulation | |||
| Description | Anesthesia conduction needle | Anesthesia conduction needle | Same |
| Regulation No. | 21 CFR 868.5150 | 21 CFR 868.5150 | Same |
| Product Code | BSP | BSP | Same |
| Indications for | |||
| Use | Intended to be used for injection of | ||
| local anesthetics into a patient to | |||
| provide regional anesthesia | Intended to be used to inject local | ||
| anesthetics into a patient to | |||
| provide regional anesthesia | Same | ||
| Principle of | |||
| Operation – | |||
| Spinal Needle | Spinal anesthesia is a form of | ||
| regional anesthesia involving the | |||
| injection of a local anesthetic into | |||
| the subarachnoid space through a | |||
| spinal needle. | |||
| Regardless of the anesthetic agent | |||
| used, the desired effect is to block | |||
| the transmission of afferent nerve | |||
| signals from peripheral | |||
| nociceptors. Sensory signals from | |||
| the site are blocked, thereby | |||
| eliminating pain. | Spinal anesthesia is a form of | ||
| regional anesthesia involving the | |||
| injection of a local anesthetic into | |||
| the subarachnoid space through | |||
| a spinal needle. | |||
| Regardless of the anesthetic | |||
| agent used, the desired effect is | |||
| to block the transmission of | |||
| afferent nerve signals from | |||
| peripheral nociceptors. Sensory | |||
| signals from the site are blocked, | |||
| thereby eliminating pain. | Same | ||
| Principle of | |||
| Operation – | |||
| Epidural | |||
| Needle | Epidural anesthesia is a regional | ||
| anesthesia that blocks pain in a | |||
| particular region of the body. An | |||
| epidural needle is used to inject | |||
| local anesthetic agent into the | |||
| epidural space of the spinal cord | |||
| to block the pain. To provide | |||
| continuous epidural anesthesia, a | |||
| small hollow catheter is threaded | Epidural anesthesia is a regional | ||
| anesthesia that blocks pain in a | |||
| particular region of the body. An | |||
| epidural needle is used to inject | |||
| local anesthetic agent into the | |||
| epidural space of the spinal cord | |||
| to block the pain. To provide | |||
| continuous epidural anesthesia, a | |||
| small hollow catheter is threaded | Same | ||
| through the epidural needle into | |||
| the epidural space and left there | |||
| while the needle is removed. | through the epidural needle into | ||
| the epidural space and left there | |||
| while the needle is removed. | |||
| Intended | |||
| Patient | |||
| Population | Adult and child | Adult and child | Same |
| Material Specifications | |||
| Needle/cannula | |||
| material | Cold-rolled stainless steel | ||
| (JIS G4305-SUS304) | Cold-rolled stainless steel | ||
| (JIS G4305-SUS304) | Same | ||
| Cannula depth | |||
| markings | The system to cause a chemical | ||
| change of the metal ion on the | |||
| surface to a black color by | |||
| electrolysis without changing the | |||
| material of cannula. | The system to cause a chemical | ||
| change of the metal ion on the | |||
| surface to a black color by | |||
| electrolysis without changing the | |||
| material of cannula. | Same | ||
| Stylet material | Spinal Needle: Stainless steel wire | ||
| for spring | |||
| Epidural Needle: Stainless steel | |||
| wire for spring | Stainless steel wire for spring | ||
| Epidural Needle: Stainless steel | |||
| wire for spring | Same | ||
| Stylet hub | |||
| material | Polycarbonate | Polycarbonate | Same |
| Retaining plate | |||
| (Plunger) | Polycarbonate | Polycarbonate | Same |
| Final Needle | |||
| assembly | |||
| protection | Protector (polyethylene) | Protector (polyethylene or | |
| polypropylene) | Similar | ||
| Minor | |||
| difference | |||
| (*1) | |||
| Sterilization | |||
| Method | Sterile EO (=ETO) | Sterile ETO | Same |
| Sterile package | Peel open type package using | ||
| laminate film of polyester and | |||
| polyethylene / Tyvek high density | |||
| polyethylene or medical grade | |||
| craft paper | Peel open type package using | ||
| laminate film of polypropylene or | |||
| polyethylene / polyethylene of | |||
| high density or medical grade | |||
| craft paper | Similar | ||
| Minor | |||
| difference | |||
| (*2) |
COMPARISON OF TECHNICAL CHARACTERISTICS
5
Comparison Table of devices - Subject device
| Dr.J Brand | Item no | Length | Gauge | Point |
|---|---|---|---|---|
| Spinal Needle | 18Gx90mm (3.5") | 3.5" | 18G | K-3 |
| Spinal Needle | 19Gx90mm (3.5") | 3.5" | 19G | K-3 |
6
| Spinal Needle | 20Gx90mm (3.5") | 3.5" | 20G | K-3 |
|---|---|---|---|---|
| Spinal Needle | 22Gx90mm (3.5") | 3.5" | 22G | K-3 |
| Spinal Needle | 25Gx90mm (3.5") | 3.5" | 25G | K-3/ Pencil |
| Spinal Needle | 26Gx90mm (3.5") | 3.5" | 26G | K-3/ Pencil |
| Spinal Needle | 27Gx90mm (3.5") | 3.5" | 27G | K-3/ Pencil |
| Epidural Needle | 16Gx90mm (3.5") | 3.5" | 16G | Tuohy |
| Epidural Needle | 17Gx90mm (3.5") | 3.5" | 17G | Tuohy |
| Epidural Needle | 18Gx90mm (3.5") | 3.5" | 18G | Tuohy |
| Epidural Needle | 20Gx90mm (3.5") | 3.5" | 20G | Tuohy |
Comparison Table of devices – Predicate device
| Phoenix Brand | Item no | Length | Gauge | Point |
|---|---|---|---|---|
| Spinal Needle | 18Gx90mm (3.5") | 3.5" | 18G | K-3 |
| Spinal Needle | 19Gx90mm (3.5") | 3.5" | 19G | K-3 |
| Spinal Needle | 20Gx90mm (3.5") | 3.5" | 20G | K-3 |
| Spinal Needle | 22Gx90mm (3.5") | 3.5" | 22G | K-3 / Pencil |
| Spinal Needle | 25Gx90mm (3.5") | 3.5" | 25G | K-3/ Pencil |
| Spinal Needle | 26Gx90mm (3.5") | 3.5" | 26G | K-3/ Pencil |
| Spinal Needle | 27Gx90mm (3.5") | 3.5" | 27G | K-3/ Pencil |
| Epidural Needle | 16Gx90mm (3.5") | 3.5" | 16G | Tuohy |
| Epidural Needle | 17Gx90mm (3.5") | 3.5" | 17G | Tuohy |
| Epidural Needle | 18Gx90mm (3.5") | 3.5" | 18G | Tuohy |
| Epidural Needle | 20Gx90mm (3.5") | 3.5" | 20G | Tuohy |
Discussion of Similarities
The subject device and the predicate device have the same intended use, design, technological characteristics and similar materials.
Discussion of Differences
- *1: Predicate device used 2 types of protector, made in either polyethylene or polypropylene while subject device used only 1 type in polyethylene (in same material and specification as predicate device).
- *2: Tyvek high density polyethylene used in subject device showed similar safety and stability as polyethylene of high density used in predicate device. See Section 14 for test results.
- *3: Models of subject device (needle specification, gauge size and length etc.) are all included in the family of predicate device.
7
SAFETY AND EFFECTIVENESS CONCLUSIONS:
This submission represents only a modification to the outer box for the currently marketed predicate. Therefore, the similarities between the subject device and predicate device are numerous (as shown in the comparison table). These equivalencies combine to justify a substantially equivalent determination.
Shelf life – Packaging testing, Shelf life- Functionality testing and Sterilization (See Section 14 and Section 18) were conducted to show that the safety, integrity or functional characteristics of the subject device is assured.
8
SUMMARY OF NON-CLINICAL TESTING
Nonclinical testing as shown in the summary below was conducted to ensure the safety and effectiveness of subject device. Subject device passed all the testing and successfully demonstrate that subject device is as safe, as effective, and performs as well as legally marketed device predicate.
| Category | Evaluation | Test Criteria |
|---|---|---|
| Functional | ||
| Performance | Stability test bonding to | |
| hub | ISO 7864 Sterile hypodermic needles for single use -- | |
| Requirements and test methods | ||
| Stability test bending | ||
| rigidity | ISO 9626 Stainless steel needle tubing for the | |
| manufacture of medical devices -- Requirements and test | ||
| methods | ||
| Penetration force and drag | ||
| force for needles | ISO 7864 Sterile hypodermic needles for single use -- | |
| Requirements and test methods | ||
| Breakage test | ISO 9626 Stainless steel needle tubing for the | |
| manufacture of medical devices -- Requirements and test | ||
| methods | ||
| Fluid leakage test | ISO 80369-7 Small-bore connectors for liquids and | |
| gases in healthcare applications -- Part 7: Connectors for | ||
| intravascular or hypodermic applications | ||
| Separation axial load test | ISO 80369-7 Small-bore connectors for liquids and | |
| gases in healthcare applications -- Part 7: Connectors for | ||
| intravascular or hypodermic applications | ||
| Separation unscrewing | ||
| test | ISO 80369-7 Small-bore connectors for liquids and | |
| gases in healthcare applications -- Part 7: Connectors for | ||
| intravascular or hypodermic applications | ||
| Overriding test | ISO 80369-7 Small-bore connectors for liquids and | |
| gases in healthcare applications -- Part 7: Connectors for | ||
| intravascular or hypodermic applications | ||
| Stability test bonding to | ||
| hub | ISO 7864 Sterile hypodermic needles for single use -- | |
| Requirements and test methods | ||
| Stability test bending | ||
| rigidity | ISO 9626 Stainless steel needle tubing for the | |
| manufacture of medical devices -- Requirements and test | ||
| methods | ||
| Dye Penetration Test | ASTM F 1929-15 Standard Test Method for Detecting | |
| Seal Leaks in Porous Medical Packaging by Dye | ||
| Penetration Method A | ||
| Seal Strength: | EN 868-5:18 Packaging for terminally sterilized medical | |
| devices. Sealable pouches and reels of porous and | ||
| plastic film construction. Requirements and test methods | ||
| Annex D | ||
| ASTM D4169-16 Standard Practice for Performance | ||
| Testing of Shipping Containers and Systems DC13 | ||
| ASTM F1886/ F1886M-09 Standard Test Method for | ||
| Determining Integrity of Seals for Flexible Packaging by | ||
| Visual Inspection. | ||
| Packaging | Transit Test | |
| Sterility | GB/T14233 2-2005 Test methods for medical | |
| infusions, blood transfusions and injection device - Part 2: | ||
| Biological test methods | ||
| Residuals | ISO10993-7 Biological evaluation of medical | |
| devices -- Part 7: Ethylene oxide sterilization residuals | ||
| EO: GB/T14233.1 Test methods for medical | ||
| infusions, blood transfusions and injection device - Part 1: | ||
| Chemical analysis method | ||
| ECH: ISO10993-7 Biological evaluation of medical | ||
| devices -- Part 7: Ethylene oxide sterilization residuals | ||
| Sterilization | ||
| Bioburden | ISO11737-1 Sterilization of health care products -- | |
| Microbiological methods -- Part 1: Determination of a | ||
| population of microorganisms on products | ||
| Biocompatibility | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices -- |
| Part 5: Tests for in vitro cytotoxicity | ||
| Intracutaneous Reactivity | ISO 10993-10 Biological evaluation of medical devices - |
- Part 10: Tests for irritation and skin sensitization |
| | Irritation | ISO 10993-10 Biological evaluation of medical devices - - Part 10: Tests for irritation and skin sensitization |
| | Sensitization | ISO 10993-10 Biological evaluation of medical devices - - Part 10: Tests for irritation and skin sensitization |
| | Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices - - Part 11: Tests for systemic toxicity |
| | Hemolytic | ISO 10993-4 Biological evaluation of medical devices --
Part 4: Selection of tests for interactions with blood |
| | Pyrogen | ISO 10993-11 Biological evaluation of medical devices - - Part 11: Tests for systemic toxicity |
Summary of Non-Clinical Testing
9
SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of subject device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate device. The only difference between marketed predicate device and subject device is a modification to the outer box.
No new issues of safety and effectiveness questions are raised by the subject device when compared to the predicate device.