K Number
K051073
Device Name
MIDIVIEW SERIES OF MICROENDOSCOPES
Date Cleared
2006-05-17

(386 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millennium Devices Inc. Midiview Series of MicroEndoscopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures. The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.
Device Description
The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors. All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.
More Information

Not Found

No
The description focuses on the physical components and functionality of a fiber optic endoscope, with no mention of AI or ML for image analysis, diagnosis, or any other purpose.

Yes
The device is explicitly stated to be used for both diagnostic and therapeutic surgical procedures, and its description mentions working channels for tools like drills and stone baskets to facilitate therapeutic procedures.

Yes

The "Intended Use / Indications for Use" section states that the devices are intended for "visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures" and for the "diagnosis and treatment of salivary gland diseases." The "Device Description" also mentions that the tools inserted through the working channels allow the endoscopes to be used in "therapy as well as diagnosis of disease."

No

The device description clearly outlines physical hardware components such as fiber optic bundles, lenses, sheaths, and working channels, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures." This describes a device used in vivo (within the body) for direct observation and intervention.
  • Device Description: The description details a fiber optic endoscope used for visualization and manipulation within the body. It mentions working channels for surgical tools.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any analysis of biological specimens in vitro.

The device is a surgical endoscope used for direct visualization and therapeutic procedures within the body, which falls under the category of medical devices used in vivo, not in vitro.

N/A

Intended Use / Indications for Use

The Arthroview is intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.
The Microview Series of Microendosocopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.
The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.
The Sinoview is intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.

Additionally, the device is intended for use to examine body cavities, hollow organs and canals, and, using additional accessories, to perform various diagnostic and therapeutic procedures in the following surgical specialties:
Plastic and Reconstructive Surgery
General Surgery
Ear, Nose and Throat Surgery (Various diagnostic and therapeutic procedures including but not limited to the diagnosis and treatment of salivary gland diseases.)
Ophthalmic Surgery (Various diagnostic and therapeutic procedures including but not limited to lacrimal duct visualization and obstruction removal.)
Urology
Gastroenterology
Endocrinology
Orthopedic Surgery (Various diagnostic and therapeutic procedures including but not limited to the arthroscopic diagnosis and treatment of joint diseases.)

Product codes

CGM, CGQ, KYH, GCJ

Device Description

The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site.

All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors.

All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.

The probe assembly of all of the predicate devices mentioned, such as DOFI Communications Inc. Miniature Endo/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (K011189) Karl Storz Inc. Sialoendoscope and accessories (K012527), Davite Technologies Davlite Micro Endoscope and Accessories (K020310), Akermann Instrumente Laparoscopes and Accessories (K974382) as well as all of the MDI Microendoscopes consists of a fiber optic core. All of the fibers for all of the predicates and the MDI scopes are manufactured by one of two companies based in Japan. These are Fujikura Inc. sond Sumitomo Corn. Therefore, the performance of these elements will be substantially equivalent regardess of scope chosen.

Fiber optic bundles that transports light energy into the operative site surround this core. incerted to alle inserted to allow a therapeutic function. A metal sheath of either stainless steel construction surrounds the probe. The probe is semi rigid that aids in insertion and manipulation. The lens system provides 0° Direction of View (directly ahead). The Field of View in Air is 50 to 60 degrees, in Water, 40 degrees for all scopes but the Sialoview T3, which is 40 degrees. The MidiView Sinoview scope is flexible and can angle the proximal end 70 degrees. All scopes of the MidiView series incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the predicates also include an irrigation channel.

The fiber bundles and working channel tubing in all predicates and the Midi View Serie are encased in a flexible sheath of varying lengths. This sheath terminates in an ocular that is 8.5X ( in the case of the MDI devices) magnification and allows the surgeon to view the operative site directly.

In addition, a second outlet from the sheath allows the endoscope to be connected to a video converter to provide TV monitor viewing of the operative sight or record the procedure on standard video recorders. This is true of all predicates and MidiView scopes.

All of the accessories sold for the Midi View Series of scopes, such as stone baskets, biopsy needles, drills, etc. are based upon the same engineering principles, materials and theory of operation as the predicate devices. Only size will vary from device to device. This is particularly true when comparing the Midi View devices against those of the Ackermann products covered under K974382, since Ackermann Instrumente is the supplier for these accessories to Midi View Inc.

All of the materials of construction are biocompatible as per the Tripartite Modified Matrix or by actual testing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body cavities, hollow organs, canals, salivary glands, lacrimal ducts, joints

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified surgeons

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)

The Millennium Devices MDI-View series of endoscopes and accessories has been designed to and will be tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
EN 60601-1-18 Collateral Standard
EN 60601-1-2:2001 Electromagnetic Compatibility
FCC Part 18 EMC Requirements

Non-Clinical Tests for Determination of Substantial Equivalence:
Surface Temperature Tests
Optical Resolution Tests
Material Biocompatibility tests
Electrical Dielectric Strength tests
EMC testing
Sterility Testing

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K983527, K011189, K012527, K020310, K974382

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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17

510(k) SUMMARY - The Millennium Devices MDI-VIEW Series of Exhibit E Endoscopes and Accessories

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

1. Submitter's Identification

Submitter's Name: Address: Telephone Number: Contact Person:

Millennium Devices Inc. 250 Gibbs Road, Islandia, NY 11749 631 582 8440 Dr. Joseph Librizzi, President

Date Prepared:

2. Name of Device

Proprietary Name:Midi View Series of Microendoscopes
Common/Usual Name:Micro Endoscopes and Accessories
Classification Name:Endoscopes, Rigid
Classification:CGM, CGQ and KYH

3. Predicate Device Information

The FDA has cleared dozens of predicate devices with design theory and specifications very close to if not exactly the same as the Millennium Devices MDI-View MicroFibreEndoscope series of endoscopes and accessories. A small cross section of predicates is included in this submission for review.

DOFI Communications Inc. Miniature Endo/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (K011189) Karl Storz Inc. Sialoendoscope and accessories (K012527) Davlite Technologies Davlite Micro Endoscope and Accessories (K020310). Akermann Instrumente Laparoscopes and Accessories (K974382)

4. Device Description

The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site.

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All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors.

All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.

5

Intended Use: used to examine body cavities, hollow organs and canals, and, using additional accessories, to perform various diagnostic and therapeutic procedures in the following surgical specialties

Plastic and Reconstructive Surgery General Surgery

Ear, Nose and Throat Surgery

Various diagnostic and therapeutic procedures including but not limited to the diagnosis and treatment of salivary gland diseases.

Ophthalmic Surgery

Various diagnostic and therapeutic procedures including but not limited to lacrimal duct visualization and obstruction removal.

Urology

Gastroenterology

Endocrinology

Orthopedic Surgery

Various diagnostic and therapeutic procedures including but not limited to the arthroscopic diagnosis and treatment of joint diseases.

6. Comparison to Predicate Device

The probe assembly of all of the predicate devices mentioned, such as DOFI Communications Inc. Miniature Endo/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (K011189) Karl Storz Inc. Sialoendoscope and accessories (K012527), Davite Technologies Davlite Micro Endoscope and Accessories (K020310), Akermann Instrumente Laparoscopes and Accessories (K974382) as well as all of the MDI Microendoscopes consists of a fiber optic core. All of the fibers for all of the predicates and the MDI scopes are manufactured by one of two companies based in Japan. These are Fujikura Inc. sond Sumitomo Corn. Therefore, the performance of these elements will be substantially equivalent regardess of scope chosen.

Fiber optic bundles that transports light energy into the operative site surround this core. incerted to alle inserted to allow a therapeutic function. A metal sheath of either stainless steel

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construction surrounds the probe. The probe is semi rigid that aids in insertion and manipulation. The lens system provides 0° Direction of View (directly ahead). The Field of View in Air is 50 to 60 degrees, in Water, 40 degrees for all scopes but the Sialoview T3, which is 40 degrees. The MidiView Sinoview scope is flexible and can angle the proximal end 70 degrees. All scopes of the MidiView series incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the predicates also include an irrigation channel.

The fiber bundles and working channel tubing in all predicates and the Midi View Serie are encased in a flexible sheath of varying lengths. This sheath terminates in an ocular that is 8.5X ( in the case of the MDI devices) magnification and allows the surgeon to view the operative site directly.

In addition, a second outlet from the sheath allows the endoscope to be connected to a video converter to provide TV monitor viewing of the operative sight or record the procedure on standard video recorders. This is true of all predicates and MidiView scopes.

All of the accessories sold for the Midi View Series of scopes, such as stone baskets, biopsy needles, drills, etc. are based upon the same engineering principles, materials and theory of operation as the predicate devices. Only size will vary from device to device. This is particularly true when comparing the Midi View devices against those of the Ackermann products covered under K974382, since Ackermann Instrumente is the supplier for these accessories to Midi View Inc.

All of the materials of construction are biocompatible as per the Tripartite Modified Matrix or by actual testing.

7. Safety and Performance Data

The Millennium Devices MDI-View series of endoscopes and accessories has been designed to and will be tested to pass the following Voluntary Standards:

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-18 Collateral Standard EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements

    1. Software Validation There is no software associated with this product.
  • ਹੋਂ. Sterilization Validations All Micro endoscopes have been or will be validated for an SAL-6 sterility by ETO gas. Validation statements are contained in Erribit J.
  • Non-Clinical Tests for Determination of Substantial Equivalence: 10.

Surface Temperature Tests Optical Resolution Tests

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Material Biocompatibility tests Electrical Dielectric Strength tests EMC testing Sterility Testing

11. Conclusions

Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Millennium Devices Inc. has concluded that The Millennium Devices MDI-View series of endoscopes and accessories is substantially equivalent to the DOFI Communications Inc. Minature Endo/Laparoscope and accessories, (K983527), the Acueity In.c. ViaDuct Micro endoscope and Accessories (K011189), the Karl Storz KSEA sialoendoscope and accessories (K012527) and the Davlite Technologies Davlite Micro endoscope and accessories (K020310), and Akermann Instrumente Laparoscopes and Accessories (K974382).

4

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center of the seal is an abstract image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and two snakes intertwined around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Millennium Devices, Inc. % Joseph Librizzi, PhD President 250 Gibbs Road Islandia, New York 11749

Re: K051073

Trade/Device Name: Millennium Devices Inc. Midiview Series of MicroEndoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 11, 2006 Received: April 14, 2006

Dear Dr. Librizzi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.

5

Page 2 - Joseph Librizzi, PhD

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mallory

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051073 Device Name: Millennium Devices Inc. Midiview Series of MicroEndoscopes

Indications For Use: (Continued)

Endoscope TypeTrade NamePart NumberIndication for Use
ArthroscopeArthroviewMDI-002000The Arthroview is intended for use
in providing access to and
visualization of body cavities,
organs and canals to perform
various diagnostic and therapeutic
surgical procedures
MicroendoscopesMicroview
Microview TMDI-003000
MDI-003100The Microview Series of
Microendosocopes are intended for
use in providing access to and
visualization of body cavities,
organs and canals to perform
various diagnostic and therapeutic
surgical procedures

Prescription Use AND/OR Over-The-Counter Use X ... ........................................................................................................................................................................ (Part 21 CFR 801 Subpart D) (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) Page 1 of

e2m2

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051073

7

Image /page/7/Picture/0 description: The image shows the text "K051073" written in a handwritten style. The text appears to be a code or identifier, possibly related to a document or item. The handwriting is clear and legible, with a slight slant to the right.

Page 272

Exhibit C: Indications for Use

510(k) Number (if known): K051073 Device Name: Millennium Devices Inc. Midiview Series of MicroEndoscopes

Indications For Use:

| Endoscope

TypeTrade NamePart NumberIndication for Use
SialoscopeSialoview T
Sialoview T3
SialoviewMDI - 004000
MDI - 004100
MDI - 004200The Sialoview series of
microendoscopes are for use by
qualified surgeons for the diagnosis
and treatment of salivary gland
diseases. The Sialoview scopes
are used to visualize the surgical
site in salivary gland diagnosis and
therapeutic procedures.
NasosinuscopeSinoviewMDI - 001000The Sinoview is intended for use in
providing access to and
visualization of body cavities,
organs and canals to perform
various diagnostic and therapeutic
surgical procedures

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of D valuation (ODE) Page 1 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_kosto73