(28 days)
The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.
The PacScan™ Plus is the latest generation ophthalmic biometry instrument introduced by industry leading Sonomed. The series consists of two different models: PacScan™ 300A+. This A-scan system allows for measuring the axial length 0 (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. PacScan™ 300AP+. This system seamlessly integrates the A-Scan and 0 Pachymeter capabilities into a single system. All systems utilize a high-resolution, color backlit touch screen liquid crystal display (LCD) by which the user can enter information and view data and calculations. Each system also includes a built-in thermal printer. The system is compact and lightweight thereby making the system extremely portable.
The provided 510(k) summary for the PacScan Plus device does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.
Instead, the summary focuses on:
- Substantial Equivalence: It claims that the PacScan Plus is substantially equivalent to two predicate devices (Sonomed Inc.'s 4000P Pachymeter System and E-Z Scan 5500+ A-Scan / B-Scan System). This means the device's safety and effectiveness are based on its similarity to legally marketed devices, rather than on proving specific performance metrics against pre-defined acceptance criteria.
- Safety, EMC, and Performance Data (Pending/General): It states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1 and IEC 60601-2-37are currently pending and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All tests results were satisfactory." This is a general statement about standard compliance for safety and electromagnetic compatibility, not about clinical performance or acceptance criteria for measurements like axial length or corneal thickness.
- Indications for Use: The device is intended to capture measurements like axial length, anterior chamber depth, and corneal thickness with accuracy and precision as an aid in IOL power calculation. However, no specific numerical thresholds or a study demonstrating this accuracy and precision are provided.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided document.
Based on the provided text, the following information is NOT available and therefore cannot be reported:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance study details.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusions from the document:
- Device Type: Diagnostic ultrasound system for ophthalmic biometry (A-scan and Pachymeter).
- Purpose: Measures axial length, anterior chamber depth, and lens thickness; calculates IOL power; measures corneal thickness.
- Basis for Clearance: Substantial equivalence to predicate devices (Sonomed 4000P Pachymeter System and Sonomed E-Z Scan 5500+ A-Scan / B-Scan System).
- Safety & Performance Testing: General compliance with IEC 60601-1, IEC 60601-2-37 (pending at the time of submission), and EN/IEC 60601-1-2(2001) for EMC. No specific clinical performance study details are given.
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K0926637
SEP 2 4 2009
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92
Date: July 31, 2009
- Company and Correspondent making the submission: 1. Name: Sonomed Inc. Address: 1979 Marcus Ave Lake Success, NY, 11798 U.S.A. Telephone: 516-354-0900 Fax: 516-354 Website: www.sonomed.com Contact: Mr. Charles C. O'Neal, Quality Manager E-mail: coneal@escalonmed.com
-
- Device:
| Trade/proprietary name: | PacScan Plus |
|---|---|
| Common Name: | Diagnostic ultrasound system |
| Classification Name: | System, imaging, pulsed echo, ultrasonic |
- Predicate Devices:
| Manufacturer: | Sonomed, Inc. |
|---|---|
| Device: | 4000P Pachymeter System |
| 510(k) Number: | 123 |
| Manufacturer: | Sonomed, Inc. |
|---|---|
| Device: | E-Z Scan 5500+ A-Scan / B-Scan System |
| 510(k) Number: | 123 |
- Classification Names & Citations: 4. Classification: Class 2
Classification Code: 21CFR 892.1560, 1570, IYO, ITX, system, imaging, pulsed · echo, ultrasonic,
5. Description:
The PacScan™ Plus is the latest generation ophthalmic biometry instrument introduced by industry leading Sonomed. The series consists of two different models:
- PacScan™ 300A+. This A-scan system allows for measuring the axial length 0 (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens.
- PacScan™ 300AP+. This system seamlessly integrates the A-Scan and 0 Pachymeter capabilities into a single system.
All systems utilize a high-resolution, color backlit touch screen liquid crystal display (LCD) by which the user can enter information and view data and calculations. Each system
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also includes a built-in thermal printer. The system is compact and lightweight thereby making the system extremely portable.
-
Indications for Use: 6.
The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision. -
- Comparison with predicate device:
Sonomed, Inc. believes that the technologies incorporated into the PacScan Plus are substantially equivalent to those of the 4000P pachymeter system and the E-Z Scan 5500+ A-scan / B-scan system.
- Comparison with predicate device:
-
- Safety, EMC and Performance Data:
Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1 and IEC 60601-2-37are currently pending and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All tests results were satisfactory.
- Safety, EMC and Performance Data:
-
- Conclusions:
In accordance with the Federal Food. Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification Sonomed. Inc. concluded that the PacScan Plus is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
- Sonomed Inc. will update and include in this summary any other information deemed reasonably necessary by the FDA.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes above a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
P 9 4 2009
Mr. Charles C. O'Neal Quality Manager Sonomed. Inc. 1979 Marcus Ave., Suite 105C LAKE SUCCESS NY 11042
Re: K092637
Trade/Device Name: PAC Scan Plus Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: August 5, 2009 Received: August 27, 2009
Mr. O'Neal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the PAC Scan Plus, as described in your premarket notification:
Transducer Model Number
A-Mode and Pachymeter
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
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Page 2 - Mr. O'Neal
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.
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Special 510(K) Application - PacScan Plus Ophthalmic Ultrasound System Section 6 - Indications for Use
510(k) Number (if known): K092637
Device Name: Pac Scan Plus
Indications for Use
Indication for Use:
The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraccular measurements. The system's principal application is to serve as an aid in the association of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | A-Mode and Pachymeter | ||||||
| Fetal Imaging & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Prescription Use
(21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Page 1 of
evices (OIVD)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.