VOYAGER PERSONAL IMAGING DEVICE

{0}------------------------------------------------ MAR 2 2 2005 K050551 | Document No.: VPID-510k | Voyager™ | Page 6 of 47 | |-------------------------|-----------------------------|--------------| | Revision: 1.2 | Compact Imaging Device | | | Date: 15 March 2005 | 510(k) Premarket Submission | | # 510(k) Summary of Safety and Effectiveness This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21 CFR, part 807, Subpart E, Section 807.92. ### 1) Submitter's name, address, telephone number, contact person: Ardent Sound, Inc. 33 South Sycamore St. Mesa, AZ 85202 #### Paul Jaeger Corresponding Official: Sr. Principal Engineer p.jaeger@ardentsound.com E-mail: 480-649-1806 Telephone: 480-649-1605 Facsimile: February 1, 2005 Date of preparation: ### 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: Common/Usual Name Diagnostic Ultrasound System with Accessories #### Proprietary Name Voyager Ultrasound Device #### Classification: Regulatory Class II Review Category: Tier II | | 21 CFR# | Prod. Code | |---------------------------------------|----------|------------| | Ultrasonic Pulsed Echo Imaging System | 892.1560 | PC 90-IYO | | Diagnostic Ultrasonic Transducer | 892.1570 | PC 90-ITX | ### Substantial equivalence claimed to: | Trade Name | Manufacturer | 510(k) | |------------|---------------------|---------| | DIASUS | Dynamic Imaging Ltd | K013142 | | AU5 | Esaote | K980468 | | AU5/3D | Esaote | K000681 | The Voyager is of comparable type and substantially equivalent to the legally marketed 510(k) Summary of Safety and Effectiveness Page 1 of 3 Ardent Sound, Inc. 33 S. Sycamore St. Mesa, AZ 85202 {1}------------------------------------------------ | Document No.: VPID-510k | VoyagerTM<br>Compact Imaging Device<br>510(k) Premarket Submission | Page 7 of 47 | |-------------------------|--------------------------------------------------------------------|--------------| | Revision: 1.2 | | | | Date: 15 March 2005 | | | Dynamic Imaging Diasus, Esaote AU5 Ultrasound Imaging System and AU5 with 3D Imaging Dynamic Intaging Diasus, Esable 1109 Staracteristics, is comparable in key safety and effectiveness Mode. It has the same technology charaction of the predicative in the predicative devices. Additional Substantial Equivalence Information is provided in the following Comparison to Predicate Devices table.(Page 17, Table 2.) #### Description: Description. The devices referenced in this submission represent a highly portable, software-controlled, I he devices releveled in this submission costs . This submission does not include technology or diagnostic untrasound system will accosses in indications for use different from those demonstrated Comfor Cature Changes nor Corraneting in ultrasound B-Mode, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 4 MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 10 MHz; Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model. Voyager complies with the following standards: - a) IEC 60601-1, Part 1: General requirements for safety. - b) IEC 60601-1-2, Part 1: General requirements for safety, 2. Collateral standard: Electromagnetic compatibility - Requirements and tests. - c) IEC 60601-1-4, Part 1: General requirements for safety, 4. Collateral standard: Programmable electrical medical systems. - d) IEC 60601-2-37:2004-08 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. 510(k) Summary of Safety and Effectiveness {2}------------------------------------------------ #### Intended use: The intended use of this system and its accessories are as follows (all derived from B-Mode operation): Imaging: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance. ### Summary of technological characteristics: Summary of technological characteristics or features or indications for use in this Submission I here are not previously evaluated and approved in the predicate devices, nor are there such that are not provisions over indications for use not commonly used in the practice of diagnostic ultrasound. #### Testing: The Voyager Ultrasound System and its accessories are designed for compliance to all applicable The Voyager Starety standards, as referenced in Section 4. Prior release for manufacturing, all medical devices, so designed, are tested and determined to be in full compliance with acoustic such to rioco, so dolgined, and disinfection effectiveness. No additional clinical testing is output, clooompations', creaming are not a novel indication as shown by the predicate devices in required, as the marcation for this system are limited to B-mode exclusively. Ardent Sound, Inc. believes that the acoustic testing, conformance to the standards listed herein Ardent council, met belief to 21 Good Manufacturing Practices, both confirm and ensure and Tractic o conivalence with respect to safety and effectiveness to the predicate devices identified. 510(k) Number: None currently exists. Device Name: Voyager Compact Imaging Device 510(k) Summary of Safety and Effectiveness {3}------------------------------------------------ Image /page/3/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 resembling an eagle or bird in flight, composed of three curved lines. Public Health Service MAR 2 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ardent Sound, Inc. c/o Mr. Mark Job Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K050551 Trade Name: Voyager™ Compact Imaging Device Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Dated: February 28, 2005 Received: March 3, 2005 #### Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion o re(i) proxim in 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 Interstate continetee pror to May 20, 1997, 1997, 1997, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, Amendinents, of to devices that have been rockers and therefore, market the device, subject to deal Federal Food, Drug, and Cosments Free et. The general controls provisions of the Act include the general controls provisions of the Frices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for This determination of backannal Unaging Device, as described in your premarket notification: Transducer Model Number C-10, 10MHz sector scan probe, 9375-0002 C-4, 4MHz sector scan probe, 9375-0001 {4}------------------------------------------------ ### Page 2 - Mr. Mark Job If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis crime mass in erepulations affecting your device can may be subject to such additional controls. Existing major regulations affe may be subject to such additional controlist Existing major sogal to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarding your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substance of the requirements of the Act that FDA has made a determination that your device of a relaxel accepcios. You must that FDA has made a delefinination that your are ros by other Federal agencies. You must or any Federal statutes and regulations daministers of registration and listing (21 l eomply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, mendably was ice requirements as schools CFR Part 807), labeling (21 CFR Part 800); good manant 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 CFR 1000 forth in the quality systems (Q5) regulation (DF CFR 1000-1050) product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the prior to shipping in I his determination of Substantial equivalence special report. This report should complete the first device, you submit a posterealited specifical and production line devices, requested information, including acoustic output measurements based on for Monufacturers information, including acousul output measurements 30, 1997 "Information for Manufacturers" If the specific in Appendix U, (enclosed) of the Center 3 beforms and Translucers." If the special Seeking Marketing Clearance of Diagnostic Onlues (e.g., acoustic output greater than approved report is incomplete of contains unaceepasse fullers (18). Ievels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and The Special report should reference in and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your premarket I nis letter will anow you to begin manuting your device to a legally marketed nonification. The I Driving of vaction for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice 10. Jose (240) 276-0120. Also, please note the regulation entitled, Comact the Ories of Course of Course of Course (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general invermational 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. {5}------------------------------------------------ Page 3 – Mr. Mark Job If you have any questions regarding the content of this letter, please contact Mr. Rodrigo Perez at (301)594-1212. Sincerely yours, Eail C. Syner Nancy C. Broadon / $$i$$ ) Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### INDICATIONS FOR USE 4.3 ### Diagnostic Ultrasound Indications for Use Form | System: | Voyager Compact Imaging Device | | | | | | | | | | |-------------------------------|------------------------------------------------------------------------------------|---|---|------------------------|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Transducer: | | | | | | | | | | | | Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | | | | | | | | 3 D | | Abdominal | | N | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | N - Thyroid and Breast | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | N | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | Additional Comments:__________________________________________________________________________________________________________________________________________________________ (Please do not write below this line=Continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Laisla teaguer (Division Sign-Off) {7}------------------------------------------------ # Voyager™ Compact Imaging Device 510(k) Premarket Submission ### Diagnostic Ultrasound Indications for Use Form | System: | Voyager Compact Imaging Device | | | | | | | | | | | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---|---|-----|------------------------|------------------|----------------------|------------------------------|-----------------------|--------------------|--| | Transducer: | C-10, 10MHz sector scan probe, 9375-0002<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | Intended Use: | | | | | | | | | | | | | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdorninal | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | N - Thyroid and Breast | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | N | | | | | | | | | | | Laparoscopic Musculo-skeletal Conventional | | N | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | other (specif) N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:_ (PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Daniel K. Inouye (Division Sign-Off) Division of Reproductive, Abdo and Radiological Revice 5 100(8) Station beet Mesa {8}------------------------------------------------ | Document No.: | VPID-510k | |---------------|---------------| | Revision: | 1.2 | | Date: | 15 March 2005 | | | Voyager™ | |--|-----------------------------| | | Compact Imaging Device | | | 510(k) Premarket Submission | | | Page 12 of 47 | |--|---------------| |--|---------------| ### Diagnostic Ultrasound Indications for Use Form | System:<br>Transducer:<br>Intended Use: | Voyager Compact Imaging Device<br>C-4, 4MHz sector scan probe, 9375-0001 | | | | | | | | | | | |--------------------------------------------------|------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--| | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | | Mode of Operation | | | | | | | | | | | | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | N | | | | | | | | 3D | | | Abdominal | | N | | | | | | | | 3D | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | | Laparoscopic<br>Musculo-skeletal<br>Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: _________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David B. Simpson (Division Sign-Off) Division of Reproductive, A and Radiological Devic 510(k) Number . Prescription Use (Per 21 CFR 801.109) Ardent Sound, Inc. 33 S. Sycamore St. Mesa, AZ 85202