(236 days)
No
The device description and performance studies focus on the physical properties and mechanical function of a disposable needle guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device aids in a medical procedure (biopsy, fluid delivery/removal) for an internal organ or body cavity, which is a therapeutic intervention, by guiding a needle during an ultrasound.
No
Explanation: This device is a disposable needle guide designed to facilitate the accurate insertion of needles during ultrasound-guided procedures (e.g., biopsy), not to diagnose a condition itself. Its function is interventional, aiding in a procedure that might be performed after a diagnosis has been made.
No
The device description explicitly details physical components such as brackets, needle adapters, sterile gel, elastic bands, and transducer covers, and the performance studies focus on the biocompatibility and mechanical properties of these physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam." This describes a device used during a medical procedure to guide instruments within the body, not a device used to examine specimens outside the body to obtain diagnostic information.
- Device Description: The description details a physical device (bracket, needle adapter, etc.) that attaches to an ultrasound transducer to guide needles. It does not describe reagents, kits, or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information based on laboratory testing
- Use in a laboratory setting
The device is clearly intended for use in vivo (within the body) to facilitate a medical procedure (biopsy, fluid delivery/removal) guided by ultrasound. This falls under the category of a surgical or procedural accessory, not an IVD.
N/A
Intended Use / Indications for Use
"Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam."
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Internal organ, body cavity
Indicated Patient Age Range
Adult patient population
Intended User / Care Setting
Clinicians and assistant clinicians, in clinical and hospital settings.
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)
Summary of Non-Clinical Tests Performed on Subject:
Biocompatibility: The disposable Needle Guides and Grids meet ISO 10993-1 biocompatibility and ASCA- Pilot Biocompatibility Guidance requirements for limited contact duration for surface devices of breached or compromised surface external communicating tissue and indirect blood path.
- a. Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10 b.
- C. Irritation - ISO 10993-10
- Acute Systemic Toxicity— ISO 10993-11 ರ.
- e. Material-Mediated Pyrogenicity- 10993-11 and USP 151
- Direct and Indirect Hemolysis/Hemocompatibility ISO 10993-4 and ASTM F756 f.
Summary of Bench Testing Performed on Subject Device:
-
- Cover breach and probe damage testing - Water leak testing was performed during Design Input, Design Output, and Design Validation to demonstrate material attachment of needle guide over a cover did not cause damage to cover or probe.
-
- Retention and movement testing Force testing was performed on needle guide attachment to ensure a minimum force of 8N would not cause the guide to dislodge.
-
- Needle drag testing Force testing was performed by passing a cannula through the needle guide to ensure binding would not occur and force was less than a 1.5N threshold.
-
- Needle path verification testing Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design.
-
- Simulated Usability Testing - Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use as well as imaging testing conducted through laboratory evaluations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
August 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Advance Medical Designs, Inc. % David Mackie QA/RA Manager 1241 Atlanta Industrial Drive MARIETTA GA 30066
Re: K223689
Trade/Device Name: Disposable Needle Guides and Grids Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX Dated: June 21, 2023 Received: July 3, 2023
Dear David Mackie:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Yanna S. Kang -S
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
2
Indications for Use
510(k) Number (if known) K223689
Device Name Disposable Needle Guides and Grids
Indications for Use (Describe)
"Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam."
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary Advance Medical Designs, Inc. Common Name: Needle Guides & Grids This summary of Traditional 510(k) Submission of safety and effectiveness of information is being prepared in accordance with the requirements of 21 CFR 807.92. April 19, 2023 Assigned 510(k) NUMBER: K223689.
1. Submitter's Identifications:
| 510(k) owner's name: | Advance Medical Designs, Inc. |
|---|---|
| Owner/Operator #: | 1037885 |
| Establishment: | Advance Medical Designs, Inc. |
| Address: | 1241 Atlanta Industrial Drive |
| Marietta, GA 30066 USA | |
| Phone Number: | (770) 422-3125 |
| Facility Registration #: | 1037885 |
| Contact person: | David Mackie: QA/RA Manager at Advance Medical Designs, Inc. |
|---|---|
| Phone Number: | (770) 422-3125 ext. 244 |
| e-mail: | mackied@advmeddes.com |
2. Date 510(k) Summary Prepared: April 19, 2023
3. Name of Subject Device and Classification Information:
| Trade name: | Disposable Needle Guides and Grids |
|---|---|
| Regulation Number: | 21 CFR 892.1570 |
| 510(k) Number: | K223689 |
| Common Name: | Needle Guides & Grids |
| Classified Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
4. Information for the Predicate Device:
- A) PRIMARY PREDICATE DEVICE:
| Trade Name/Device Name: | Disposable Endocavity Needle / Biopsy Guide |
|---|---|
| Manufacturer: | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number: | K972514 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
4
5. Information for Reference Devices:
| A) REFERENCE DEVICE: | |
|---|---|
| Trade Name/Device Name: | Disposable Guides KDNG00 |
| Manufacturer: | KOELIS |
| 510(k) Number: | K180970 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
| B) REFERENCE DEVICE: | |
| Trade Name/Device Name: | VitroPRO / Disposable Endocavity Needle Guide |
| Manufacturer: | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number: | K222052 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
| C) REFERENCE DEVICE: | |
| Trade Name/Device Name: | Reusable Guide |
| Manufacturer: | KOELIS |
| 510(k) Number: | K141334 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
Description of Subject Device:
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
Needle Guide/Grid: ABS Stainless Steel Polypropylene
5
Rolled Latex-Free Probe Cover K011265: Polyisoprene
Rolled Latex Probe Cover K011265: Latex Rubber
20ml. Sterile Ultrasound Gel 510(k)# K163050:
Device Characteristics of Advance Medical Designs, Inc. Needle Guides and Grids:
- Hypoallergenic, non-irritating
- No toxic effects
- Produced with completely harmless material.
- Does not damage the probe.
- Non-Invasive
- Contact with only intact skin, or with breached surfaces with duration