Align® Cover and Pad Guidance Tool
Device Facts
| Record ID | K260114 |
|---|---|
| Device Name | Align® Cover and Pad Guidance Tool |
| Applicant | CIVCO Medical Instruments Co., Inc. |
| Product Code | ITX · Radiology |
| Decision Date | Sep 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
Indications for Use
The medical device is intended to provide a guide for interventional devices while also serving as a microbial barrier between the patient and the ultrasound transducer. - Abdominal - Diagnostic imaging and minimally invasive puncture procedures. - Small Parts - Diagnostic imaging and minimally invasive puncture procedures. - Regional Anesthesia - Diagnostic imaging and minimally invasive puncture procedures. - Vascular Access - Diagnostic imaging and minimally invasive puncture procedures.
Device Story
Align® Cover and Pad Guidance Tool functions as a sterile, single-use accessory for ultrasound transducers. Device consists of a probe cover, a pad, and an integrated instrument guide. During interventional procedures (e.g., biopsies, vascular access), clinician places cover/pad over transducer; guide positions interventional instrument within ultrasound beam's field of view. Device provides microbial barrier between patient and transducer; pad facilitates acoustic coupling. Used in clinical settings by physicians or trained healthcare professionals. Output is physical guidance for needle/instrument placement, enabling real-time visualization of interventional path. Benefits include improved procedural accuracy and maintenance of sterile field.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including biocompatibility (ISO 10993-1), microbial barrier performance (ASTM F1671-13), and simulated usability testing.
Technological Characteristics
Materials: Polycarbonate, silicone elastomer, polyether polyurethane, polypropylene (guide), and specialized coating (Hydromer or Aculon). Meets ASTM F1671-13 for microbial barrier and ISO 10993-1 for biocompatibility. Mechanical features include instrument holder retaining tab with spring force functionality. Sterile, single-use, non-electronic, passive mechanical guidance system.
Indications for Use
Indicated for patients undergoing abdominal, small parts, regional anesthesia, or vascular access procedures requiring diagnostic ultrasound imaging and minimally invasive puncture. Contraindicated for use outside of these clinical applications.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 24, 2026
CIVCO Medical Instruments Co., Inc.
James Leong
Regulatory Affairs
750 Lois Lane
Coralville, IA 52241
Re: K260114
Trade/Device Name: Align® Cover and Pad Guidance Tool
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic Ultrasonic Transducer
Regulatory Class: Class II
Product Code: ITX
Dated: August 26, 2026
Received: August 26, 2026
Dear James Leong:
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 (the 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 available 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.
Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260114 - James Leong
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may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K260114 - James Leong
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assistance/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,
**MARJAN NABILI -S**$^{for}$
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K260114
Please provide the device trade name(s).
Align® Cover and Pad Guidance Tool
Please provide your Indications for Use below.
The medical device is intended to provide a guide for interventional devices while also serving as a microbial barrier between the patient and the ultrasound transducer.
- Abdominal - Diagnostic imaging and minimally invasive puncture procedures.
- Small Parts - Diagnostic imaging and minimally invasive puncture procedures.
- Regional Anesthesia - Diagnostic imaging and minimally invasive puncture procedures.
- Vascular Access - Diagnostic imaging and minimally invasive puncture procedures.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K260114
1. Submitter's Identifications:
| Establishment: | CIVCO Medical Instruments Co., Inc. |
| --- | --- |
| Address: | 750 Lois Lane Coralville, IA 52241 |
| Registration Number: | 1937223 |
| Operations Manufacturer | CIVCO Medical Instruments Co., Inc. |
| Owner/Operator: | |
| Owner/Operator Number: | 1937223 |
| Contact Person: | Jim Leong |
| Phone: | 319-248-6502 |
| e-mail: | James.Leong@civco.com |
2. Date 510(k) Summary Prepared: January 12, 2026
3. Name of the Subject Device and Classification Information:
| Trade/Device Name | Align® Cover and Pad Guidance Tool |
| --- | --- |
| Regulation Number | 21 CFR 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | Class II |
| Product Code | ITX |
4. Information for the Primary Predicate Device:
| Tradename/Device Name | Envision™ Ultrasound Cover and Pad |
| --- | --- |
| Manufacturer | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number | K190802 |
| Regulation Number | 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | Class II |
| Product Code | ITX |
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# Information for the Secondary Predicate Device:
| Tradename/Device Name | Ultrasound General Purpose Guidance System |
| --- | --- |
| Manufacturer | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number | K093713 |
| Regulation Number | 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | Class II |
| Product Code | ITX |
# 5. Device Description:
The Align® Cover and Pad Guidance Tool offers a unique approach to ultrasound-guided procedures by providing a guide that positions the interventional instrument in the field of view of the ultrasound beam, as well as a microbial barrier and ultrasound conductive medium between the patient and the ultrasound transducer.
# 6. Intended Use / Indications for Use:
The medical device is intended to provide a guide for interventional devices while also serving as a microbial barrier between the patient and the ultrasound transducer.
- Abdominal - Diagnostic imaging and minimally invasive puncture procedures.
- Small Parts - Diagnostic imaging and minimally invasive puncture procedures.
- Regional Anesthesia - Diagnostic imaging and minimally invasive puncture procedures
- Vascular Access - Diagnostic imaging and minimally invasive puncture procedures
# 7. Comparison to Legally Marketed Device
| | Subject Device Align® Cover and Pad Guidance Tool | Primary Predicate Envision™ Ultrasound Cover and Pad-K190802 | Secondary Predicate Ultrasound General Purpose Guidance System (Infiniti)-K093713 |
| --- | --- | --- | --- |
| Materials | | | |
| • Pad | Polycarbonate, silicone elastomer, polyether polyurethane, coating formulation (Hydromer or Aculon) No-Tox Liquid Ink FGN-1636 NT21 Black | Polycarbonate, silicone elastomer, polyether polyurethane, coating formulation (Hydromer or Aculon) | N/A |
| • Cover | Polyurethane (and those in the pad) | Polyurethane (and those in the pad) | N/A |
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| | Subject Device Align® Cover and Pad Guidance Tool | Primary Predicate Envision™ Ultrasound Cover and Pad-K190802 | Secondary Predicate Ultrasound General Purpose Guidance System (Infiniti)-K093713 |
| --- | --- | --- | --- |
| • Guide | Polypropylene Clariant Colorant OC5SAF (Pale Blue) | N/A | ABS |
| Microbial Barrier | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | N/A |
| Biocompatibility | Meets ISO 10993-1 Biocompatibility requirements for surface devices with limited (≤ 24 hours) contact with breached or compromised surface | Meets ISO 10993-1 biocompatibility requirements for limited (≤ 24 hours) contact duration: • surface devices in contact with breached or compromised surface • external communicating device with indirect contact with blood path/tissue | Meets ISO 10993-1 Biocompatibility requirements for limited (≤ 24 hours) contact duration for external communicating devices in contact with tissue/bone/dentin |
| Shelf Life | 15 Months | 3 years | 3 years |
| Included Accessories | Sterile Saline Wipe Bands with cover configurations | Sterile Saline Wipe Bands with cover configurations | Probe Cover with gel and bands |
### 8. Comparison of Indications to the Legally Marketed Device:
The proposed Align device has the same basic intended use as the predicate, which is to help direct interventional instruments into an anatomical structure using an ultrasound transducer. CIVCO has further combined the indications for use for the Envision Cover and Pad along with the Infiniti Needle Guide into bullet point format.
- Abdominal - Diagnostic imaging and minimally invasive puncture procedures.
- Small Parts - Diagnostic imaging and minimally invasive puncture procedures.
- Regional Anesthesia - Diagnostic imaging and minimally invasive puncture procedures
- Vascular Access - Diagnostic imaging and minimally invasive puncture procedures
### 9. Summary of Non-Clinical Tests Performed:
- Biocompatibility:
The Align® Cover and Pad Guidance Tool are manufactured with materials which meet ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface. These same materials are already utilized on CIVCO cleared medical devices for contact in the same regions.
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• Design specification:
The Align® Cover and Pad Guidance Tool have certain design functionality which was tested internally to verify they meet the established requirements. These criteria are listed as follows:
○ Visual Inspection testing - This test confirms that the device is assembled correctly, there is no exposed adhesive.
○ Dimensional testing - This test confirms that the guide is properly attached to the cover and pad.
○ Adhesive Force Test - This test confirms that the device will remain attached with a minimum amount of force.
○ Spring Force and Deflection Test - This test confirms that the force to deflect the instrument holder retaining tab can deflect with a minimum amount of force and return within 10 degrees of the original position.
○ Functional Scanning Test - This test confirms the pad and cover are compatible with ultrasound imaging equipment.
○ Cover Leak Test – This test ensures manufacturing produces covers without holes.
○ Pin Slip Test - This test confirms that the device can be utilized with instruments up to 18GA in size.
○ Rehydration Test – This test ensures the coating on the Align Covers and Pads is capable of being rehydrated multiple time during a procedure.
○ Tensile Strength Test – This testing confirmed that the device demonstrates the same material tensile strength as the predicate device.
○ Tear Resistance Test - This testing confirmed that the device demonstrates the same material tear resistance as the predicate device.
○ Air Burst Pressure and Volume Testing – This test confirms mechanical integrity of the covers.
• Simulated Usability Testing
Simulated use evaluations were performed by customers to ensure the design of the Align device conforms to the user needs and intended use.
10. Clinical Test Performed:
Clinical tests were not required to demonstrate substantial equivalence.
11. Conclusions:
Given that the subject and predicate devices have the same intended use and their technological characteristics achieve the same goal even though the designs are different, there is not a different question of safety and effectiveness. Therefore, the subject device is substantially equivalent to the primary predicate device.
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