(243 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a surgical implant, with no mention of AI or ML technology.
Yes
The primary indication of the device is to reduce the development of symptomatic or painful neuroma, which directly addresses a disease condition (neuroma) and its symptoms (pain). This aligns with the definition of a therapeutic device.
No
The device is a surgical implant designed to protect a peripheral nerve end and reduce the development of neuromas, not to diagnose a condition.
No
The device description clearly states it is a "surgical implant" and describes its physical characteristics, material (porcine small intestinal submucosa), and manufacturing process. It is a physical device, not software.
Based on the provided information, the AxoGen Nerve Cap is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- AxoGen Nerve Cap Function: The AxoGen Nerve Cap is a surgical implant designed to be placed inside the body to protect a peripheral nerve end and reduce neuroma formation. It is a physical barrier and scaffold that is remodeled by the body.
- Intended Use: The intended use clearly states it is for protecting a peripheral nerve end and separating it from the surrounding environment. This is a therapeutic and protective function, not a diagnostic one.
- Device Description: The description details a surgical implant made from processed porcine tissue, designed for physical placement and integration within the body.
Therefore, the AxoGen Nerve Cap falls under the category of a surgical implant or medical device used for treatment and protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
AxoGen Nerve Cap is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of symptomatic or painful neuroma.
Product codes
JXI
Device Description
The AxoGen Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device prevents dislocation of the nerve end by pulling the nerve into the tube, suturing the nerve within the cap, and securing the tab to the surrounding tissue.
AxoGen Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. The device is manufactured from processed porcine small intestinal submucosa (SIS) which is vacuum pressed prior to packaging. After hydration, the device is easy to handle, soft, pliable, non-friable and porous.
AxoGen Nerve Cap is flexible to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized nonabsorbable suture. It is supplied in nominal tube diameters ranging from 1.5mm up to 8mm, and a length of 13mm-38mm. AxoGen Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve end
Indicated Patient Age Range
Not Found
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
Non-clinical Testing: An animal study evaluating porcine small intestine submucosa (SIS) nerve end caps in a chronic rat tibial nerve transposition (TNT) model evaluated the safety, local effects. and overall efficacy of AxoGen Nerve Caps in the reduction of painful neuroma formation. Control groups were also implanted and included a hollow tube conduit nerve cuff with an open end and a surgical control. Overall, AxoGen Nerve Caps (both Partition and Spiral) and Open Tubes nerve cuffs had similar tissue and inflammatory responses at 56 and 84 days. Furthermore, AxoGen Nerve Caps (both Partition and Spiral) were partially remodeled, but still present at 84 days post-surgery. As compared to the Surgical Controls, the Nerve Caps provided containment of nerve end and subsequent outgrowth, a reduction in nerve width measurements, and overall reduced sensitivity to mechanical stimulation, indicating a reduced likelihood of symptomatic and painful neuroma formation.
Performance Specifications:
- End Tab Shear Test: End tab is of sufficient size to hold a class I, 8-0 USP suture as measured by lap shear of a 6-layer SIS sample with an overlap representative of the device configuration.
- Suture retention strength: The suture retention of a 4-layer SIS sample (representative of the lumen material) meets specifications ($\geq$ 560.8 gf) after aging for 19 months and there was no loss of the ability of the material to hold suture after aging. The shelf life of the product is 18 months.
- Ultimate Tensile Strength: Ultimate Tensile Strength was not reduced with aging for 19 months. The shelf life of the product is 18 months.
- Usability: The usability study demonstrated that the design was sufficient to show that the Nerve Cap can cover the nerve, is easy to handle and suture, and the lumen did not collapse during handling.
Biocompatibility: A biocompatibility evaluation in accordance with ISO 10993-1 was performed.
- Cytotoxicity: Pass (Non-cytotoxic)
- Sensitization: Pass (No evidence of sensitization)
- Intracutaneous/Irritation: Pass (No evidence of intracutaneous reactivity)
- Acute Systemic Toxicity: Pass (No mortality or evidence of acute systemic toxicity)
- Subchronic/chronic Systemic Toxicity: Pass (Non-irritating to subcutaneous tissue; No evidence of subchronic or chronic toxicity)
- Genotoxicity: Pass (Device extracts are non-mutagenic)
- Implantation: Pass (Irritation not greater than control materials at 24 weeks)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).
0
510(k) Summary: K163446
Company Information
| Company Name: | AxoGen Corporation |
|---|---|
| Contact Name: | Mark Friedman, PhD |
| Contact Title: | Vice President of Requlatory Affairs and Quality Assurance |
| Address: | 13631 Progress Boulevard |
| Suite 400 | |
| Alachua, FL 32615 | |
| Phone (office): | 386-462-6800 |
| Phone (mobile): | 386-462-6820 |
| Fax: | 386-462-6801 |
| Date Prepared: | August 3, 2017 |
| Product Information | |
| Trade Name: | AxoGen Nerve Cap |
| Common Name: | Nerve Cuff |
| Classification Name: | Nerve Cuff, 21 CFR 882.5275, Product Code JXI, Class II |
| Classification Panel: | Neurology |
Predicate Devices
The AxoGen Nerve Cap is substantially equivalent to the following devices:
- Nerve Capping Device (Neurocap) K152684
- . Surgisis Nerve Cuff (AxoGuard Nerve Connector) K031069 and K162741
Indications For Use
AxoGen Nerve Cap is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of symptomatic or painful neuroma.
Device Description
The AxoGen Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device prevents dislocation of the nerve end by pulling the nerve into the tube, suturing the nerve within the cap, and securing the tab to the surrounding tissue.
AxoGen Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. The device is manufactured from processed porcine small intestinal submucosa (SIS) which is vacuum pressed prior to packaging. After hydration, the device is easy to handle, soft, pliable, non-friable and porous.
1
AxoGen Nerve Cap is flexible to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized nonabsorbable suture. It is supplied in nominal tube diameters ranging from 1.5mm up to 8mm, and a length of 13mm-38mm. AxoGen Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
Performance Specifications
The performance specifications for the AxoGen Nerve Cap are described below.
| Table 1 | |
|---|---|
| AxoGen Nerve Cap Performance Specifications | |
| Test | Results |
| End Tab Shear Test** | End tab is of sufficient size to hold a class I, 8-0 USP suture |
| as measured by lap shear of a 6-layer SIS sample with an | |
| overlap representative of the device configuration. | |
| Suture retention strength* | The suture retention of a 4-layer SIS sample (representative |
| of the lumen material) meets specifications ( $\geq$ 560.8 gf) after | |
| aging for 19 months and there was no loss of the ability of the | |
| material to hold suture after aging. The shelf life of the | |
| product is 18 months. | |
| Ultimate Tensile | |
| Strength* | Ultimate Tensile Strength was not reduced with aging for 19 |
| months. The shelf life of the product is 18 months. | |
| Usability** | The usability study demonstrated that the design was |
| sufficient to show that the Nerve Cap can cover the nerve, is | |
| easy to handle and suture, and the lumen did not collapse | |
| during handling. | |
| *Test results were drawn from authorized use of a FDA Master File on well-known and | |
| characterized materials (SIS material) | |
| **AxoGen Nerve Cap samples were used for testing |
Biocompatibilitv
A biocompatibility evaluation in accordance with ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process was performed. The patient contact was defined as follows:
Patient Contact: Direct Body Contact: Implantation Type of Tissue: Tissue/Bone Duration: Permanent (>30 days)
| Table 2 | ||||
|---|---|---|---|---|
| Biocompatibility Testing | ||||
| Biocompatibility Test | Results | |||
| Cytotoxicity | Pass | |||
| Non-cytotoxic | ||||
| Sensitization | Pass | |||
| No evidence of sensitization | ||||
| Intracutaneous/Irritation | Pass | |||
| No evidence of intracutaneous | ||||
| reactivity | ||||
| Acute Systemic Toxicity | Pass |
2
| No mortality or evidence of acute systemic toxicity | ||
|---|---|---|
| Subchronic/chronic | ||
| Systemic Toxicity | Pass | Non-irritating to subcutaneous tissue |
| No evidence of subchronic or chronic toxicity | ||
| Genotoxicity | Pass | Device extracts are non-mutagenic |
| Implantation | Pass | Irritation not greater than control materials at 24 weeks |
| Test results were drawn from authorized use of a FDA Master File on well-known | ||
| and characterized materials (SIS material) See 510(k) K162741 |
Sterilization
The AxoGen Nerve Cap is sterilized using an established ethylene oxide (EO) sterilization cycle that has been validated to a sterility assurance level (SAL) of 10th in conformance with EN ISO 11135:2014: Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Using the exhaustive extraction technique, the EO residuals for AxoGen Nerve Cap samples were verified to be less than the maximum allowable limits as defined by ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals:
Non-clinical Testing
An animal study evaluating porcine small intestine submucosa (SIS) nerve end caps in a chronic rat tibial nerve transposition (TNT) model evaluated the safety, local effects. and overall efficacy of AxoGen Nerve Caps in the reduction of painful neuroma formation. Control groups were also implanted and included a hollow tube conduit nerve cuff with an open end and a surgical control. Overall, AxoGen Nerve Caps (both Partition and Spiral) and Open Tubes nerve cuffs had similar tissue and inflammatory responses at 56 and 84 days. Furthermore, AxoGen Nerve Caps (both Partition and Spiral) were partially remodeled, but still present at 84 days post-surgery. As compared to the Surgical Controls, the Nerve Caps provided containment of nerve end and subsequent outgrowth, a reduction in nerve width measurements, and overall reduced sensitivity to mechanical stimulation, indicating a reduced likelihood of symptomatic and painful neuroma formation.
Substantial Equivalence
The AxoGen Nerve Cap is similar in intended use, design and function to the predicate device, the Polyganics Nerve Capping Device (Neurocap) cleared under 510(k) K152684. The technological similarities and differences (e.g., technological features, dimensions, materials, Intended Use, etc.) between the AxoGen Nerve Cap and the Polyganics Neurocap devices are shown in Table 3.
The primary differences include material differences, internal channels, end cap design, more sizes for the AxoGen Nerve Cap. The materials used in both devices are standard nerve cuff materials used in multiple nerve cuff products on the market today. Both devices have internal chambers/channels to reduce neuroma formation by
3
containing the nerve end and subsequent outgrowth. Both devices can be sutured to surrounding structures to hold the nerve cap device in place after implantation. Both devices have a variety of sizes allowing the surgeon to size match the proximal nerve stump. The difference in Intended Use (addition of pain to the Indication For Use statement) is supported by AxoGen's preclinical study. These differences in technological characteristics do not raise safety or effectiveness issues as both devices are designed to cap the end of a proximal nerve to reduce neuroma formation by containing the nerve end and subsequent outgrowth with the ability to attach the device to surrounding tissue.
| Table 3
| Substantial Equivalency Chart to Predicate Nerve Capping Device | ||
|---|---|---|
| Name | AxoGen Nerve Cap | Nerve Capping Device |
| (Neurocap) | ||
| 510(k) # | This submission | K152684 |
| Company | AxoGen Corporation | Polyganics Innovations BV |
| Common Name | Nerve Cuff | Nerve Cuff |
| Classification | Class II | Class II |
| Classification Product | ||
| Code | JXI | JXI |
| Classification Panel | Neurology | Neurology |
| Intended Use | AxoGen Nerve Cap is indicated | |
| to protect a peripheral nerve | ||
| end and to separate the nerve | ||
| from surrounding environment | ||
| to reduce the development of | ||
| symptomatic or painful | ||
| neuroma | The Nerve Capping Device is | |
| indicated to protect a peripheral | ||
| nerve end and to separate the | ||
| nerve from surrounding | ||
| environment to reduce the | ||
| development of a symptomatic | ||
| neuroma. | ||
| Description | AxoGen Nerve Cap is an | |
| implant manufactured from | ||
| porcine small intestinal | ||
| submucosa (SIS) and is in a | ||
| tubular form with channels and | ||
| an end cap. | Neurocap is a bioresorable | |
| peripheral nerve capping device | ||
| composed of the biocompatible | ||
| resorbable and synthetic | ||
| polymer poly(DL-lactide)-e- | ||
| caprolactone and an end cap | ||
| with a hole for suturing | ||
| Device Design | Open Tube with internal | |
| channels and one end closed. | ||
| Image: AxoGen Nerve Cap | Open Tube with one end closed. | |
| Image: Nerve Capping Device | ||
| Material Used | Porcine submucosal intestinal | |
| membrane SIS 2.0 | Poly(DL-lactide)-e-caprolactone | |
| Container | PETG Clamshell in Tyvek/Poly | |
| Chevron Pouch | Polycarbonate tray and Tyvek | |
| pouch | ||
| Single Use/Disposable | Single use only | Single use only |
| Sterile | Sterile SAL 10-6 | Sterile SAL 10-6 |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Table 3 | ||
| Substantial Equivalency Chart to Predicate Nerve Capping Device | ||
| Name | AxoGen Nerve Cap | Nerve Capping Device |
| (Neurocap) | ||
| 510(k) # | This submission | K152684 |
| Mechanism of Action | AxoGen Nerve Cap is designed | |
| to protect the peripheral nerve | ||
| end from neurotrophic agents | ||
| which can endure neuroma | ||
| formation and separate the | ||
| nerve from the surrounding | ||
| environment to prevent | ||
| adhesions of the stump to | ||
| surrounding (scar) tissue which | ||
| also may lead to the | ||
| development of a symptomatic | ||
| or painful neuroma. The | ||
| material surrounding the nerve | ||
| end would then remodel into a | ||
| layer of soft connective tissue | ||
| and function as a physical | ||
| partition between the nerve and | ||
| external stimuli at the nerve | ||
| end. The device can be sutured | ||
| to surrounding tissue with a | ||
| suture through the end cap to | ||
| any surrounding tissue. | Neurocap protects the peripheral | |
| nerve end from neurotrophic | ||
| agents which can endure | ||
| neuroma formation and separate | ||
| the nerve from the surrounding | ||
| environment to prevent | ||
| adhesions of the stump to | ||
| surrounding (scar) tissue which | ||
| also may lead to the | ||
| development of a symptomatic | ||
| neuroma. | ||
| The device can be sutured to | ||
| surrounding tissue with a suture | ||
| through the hole in end cap to | ||
| any surrounding tissue. | ||
| Biocompatible | Biocompatible | Biocompatible |
| Sizes | Length includes inner lumen | |
| length (varies with nerve | ||
| diameter and end cap length, | ||
| up to 5 mm length) | ||
| 1.5 mm ID x 13.0 mm length | ||
| 1.5mm ID x 18.0 mm length | ||
| 2.0 mm ID x 18.0 mm length | ||
| 2.0 mm ID x 23.0 mm length | ||
| 3.0 mm ID x 18.0 mm length | ||
| 3.0 mm ID x 23.0 mm length | ||
| 4.0 mm ID x 18.0 mm length | ||
| 4.0 mm ID x 23.0 mm length | ||
| 5.0 mm ID x 25.0 mm length | ||
| 6.0 mm ID x 25.0 mm length | ||
| 7.0 mm ID x 25.0 mm length | ||
| 8.0 mm ID x 28.0 mm length | ||
| 8.0 mm ID x 38.0 mm length | 1.5 mm ID x 3.0 cm length | |
| 2.0 mm ID x 3.0 cm length | ||
| 2.5 mm ID x 3.0 cm length | ||
| 3.0 mm ID x 3.0 cm length | ||
| 4.0 mm ID x 3.0 cm length | ||
| 5.0 mm ID x 3.0 cm length | ||
| 6.0 mm ID x 3.0 cm length | ||
| 7.0 mm ID x 3.0 cm length | ||
| 8.0 mm ID x 3.0 cm length |
4
5
The AxoGen Nerve Cap is similar in material, design, manufacturing (including packaging and sterilization method) as the Surgisis Nerve Cuff (distributed as the AxoGuard® Nerve Connector) cleared under 510(k) K031069 and K162741. The technological similarities and differences (e.g., Indications for Use, manufacturing forming process, dimensions, material, and mechanism of use) between the AxoGen Nerve Cap and the Surgisis Nerve Cuff devices are shown in Table 4.
The Surgisis Nerve Cuff is a material predicate and not a device function predicate. The AxoGen Nerve Cuff has a different Indication For Use from the Surgisis Nerve Cuff. However both devices are used with peripheral nerve repair while achieving different purposes. There is a difference in materials, (SIS 1.0 for Surgisis Nerve Cuff versus SIS 2.0 for AxoGen Nerve Cap). Both materials are well-known and characterized materials (SIS material) and are considered equivalent. The output of the manufacturing process (device form) is different, but the manufacturing process itself is equivalent with respect to raw materials and process controls.
These differences in technological characteristics do not raise safety or effectiveness issues as both devices are designed for peripheral nerve repair and are manufactured in an equivalent manner.
| Table 4 | ||
|---|---|---|
| Material Substantial Equivalency | ||
| Name | AxoGen Nerve Cap | Surgisis |
| Nerve Cuff | ||
| (now AxoGuard Nerve Connector) | ||
| 510(k) # | This submission | K031069 and K162741 |
| Company | AxoGen Corporation | Cook Biotech, Inc. |
| Common Name | Nerve Cuff | Nerve Cuff |
| Classification | Class II | Class II |
| Classification | ||
| Product Code | JXI | JXI |
| Classification Panel | Neurology | Neurology |
| Intended Use | AxoGen Nerve Cap is indicated to | |
| protect a peripheral nerve end and | ||
| to separate the nerve from | ||
| surrounding environment to reduce | ||
| the development of symptomatic or | ||
| painful neuroma. | The Surgisis Nerve Cuff is intended | |
| for the repair of peripheral nerve | ||
| discontinuities where gap closure | ||
| can be achieved by flexion of the | ||
| extremity. The device is supplied | ||
| sterile and is intended for one-time | ||
| use. | ||
| Description | The device is an implant | |
| manufactured from porcine small | ||
| intestinal submucosa (SIS) and is in | ||
| a tubular form with channels and an | ||
| end cap. The sizes range from | ||
| diameters of 1.5-8.0 mm and | ||
| lengths up to 38 mm. | The Surgisis Nerve Cuff is | |
| manufactured from porcine small | ||
| intestinal submucosa (SIS) and is | ||
| supplied in nominal tube diameter | ||
| range of 2-7 mm and lengths up to | ||
| 50 mm. | ||
| Device | ||
| Design/Form | Tube with channels and end cap | Open-ended tube |
6
| Table 4 | ||
|---|---|---|
| Material Substantial Equivalency | ||
| Name | AxoGen Nerve Cap | Surgisis |
| Nerve Cuff | ||
| (now AxoGuard Nerve Connector) | ||
| 510(k) # | This submission | |
| Image: AxoGen Nerve Cap | K031069 and K162741 | |
| Image: Surgisis Nerve Cuff | ||
| Material Used | SIS 2.0 | SIS 1.0 |
| Container | PETG Clamshell in Tyvek/Poly | |
| Chevron Pouch | PETG Clamshell in Tyvek/Poly | |
| Chevron Pouch | ||
| Single | ||
| Use/Disposable | ||
| Sterile | Single use only | |
| Sterile SAL 10-6 | Single use only | |
| Sterile SAL 10-6 | ||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Mechanism of | ||
| Action | AxoGen Nerve Cap is designed to | |
| protect the peripheral nerve end | ||
| from neurotrophic agents which can | ||
| endure neuroma formation and | ||
| separate the nerve from the | ||
| surrounding environment to prevent | ||
| adhesions of the stump to | ||
| surrounding (scar) tissue which also | ||
| may lead to the development of a | ||
| symptomatic or painful neuroma.. | ||
| The material surrounding the nerve | ||
| end would then remodel into a layer | ||
| of soft connective tissue and | ||
| function as a physical partition | ||
| between the nerve and external | ||
| stimuli at the nerve end. The device | ||
| can be sutured to surrounding | ||
| tissue with a suture through the end | ||
| cap to any surrounding tissue. | The Surgisis Nerve Cuff is designed | |
| to be a flexible, resorbable and | ||
| semipermeable tubular membrane | ||
| matrix to provide a protective | ||
| environment for peripheral nerve | ||
| repair after injury and to create a | ||
| conduit for axonal growth across a | ||
| nerve gap | ||
| Manufacturing | ||
| Method | Manufacturing results in a closed | |
| tube with channels | Manufacturing results in a simple | |
| round open-ended tube | ||
| Biocompatible | Biocompatible | Biocompatible |
7
Conclusion
The non-clinical data and the device verification and validation demonstrate that the AxoGen Nerve Cap should perform as intended in the specified use conditions. The non-clinical data demonstrate that the AxoGen Nerve Cap is substantially equivalent to the predicate devices.
8
Image /page/8/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AxoGen Corporation % Ms. Wendy Perreault Consultant/principal New South Regulatory, LLC 223 Coventry Road Decatur, GA 30030
Re: K163446
Trade/Device Name: AxoGen Nerve Cap Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: July 5, 2017 Received: July 7, 2017
Dear Ms. Perreault:
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. Iisting 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
9
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely,
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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