(103 days)
Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope.
The Limaca Precision GI FNB needle is available in one size - 20G.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.
This document describes the regulatory clearance of the Precision GI device, an Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device manufactured by Limaca Medical Ltd. It is intended for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract.
The information provided in the document focuses on demonstrating substantial equivalence to a predicate device (EndoDrill® Model X biopsy instrument by Bibbinstruments AB, K212423) and, as such, does not contain a typical clinical study with specific acceptance criteria and detailed performance metrics as would be found in a study designed to prove the device meets pre-defined performance thresholds in a clinical setting.
Instead, the document details bench testing and a preclinical study to support the safety and effectiveness and demonstrate that the differences in technological characteristics do not raise new issues of safety or effectiveness.
Therefore, I cannot populate the table and answer all questions in the requested format as a conventional clinical study with explicit acceptance criteria and corresponding reported performance values is not presented.
However, I can extract the information available from the provided text regarding the performance data and study types:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it lists various "Performance Data" obtained from bench tests and a preclinical study to support substantial equivalence to a predicate device. The implied acceptance criterion for these tests is that the Precision GI device is "as safe and effective" and does not raise new issues of safety or effectiveness compared to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness | Bench tests and a preclinical study were performed to demonstrate that the device is "as safe and effective as the EndoDrill® Model X biopsy instrument" and that "minor technological differences... raise no new issues of safety or effectiveness." Specific tests conducted include: Dimensional Attributes and EUS compatibility, Shaft insertion/withdrawal force, Stopper lock operation force, Sample Acquisition, Echogenicity, Needle Deformation, Endurance to Distribution Environmental Hazards, Handle resistance force, Extender friction torque, Stylet withdrawal force, Stylet hold-in-position force, Sheath bonding strength, Axial stopper strength, Stylet bonding strength, Handle bending torque durability, Needle bonding torque strength, Tissue wrapping, Needle cyclic loading durability, Needle bonding durability, Needle tissue Penetration force, Needle bonding tensile strength, biocompatibility, and sterilization. The document concludes that "Performance data demonstrate that the Precision GI is as safe and effective as the predicate device." |
| Sample Acquisition | The reduced motor speed (800RPM vs. predicate's higher speed) "provides a good sample acquisition as demonstrated in bench tests and preclinical study." Specific quantitative metrics for sample acquisition (e.g., sample size, diagnostic yield) are not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench tests and preclinical study."
- Bench Tests: These typically involve testing of devices in a lab setting, not human subjects. Sample sizes would refer to the number of devices or components tested. This information is not provided.
- Preclinical Study: This likely refers to in vitro or in vivo animal studies. The specific sample size (number of animals or specimens) and data provenance are not provided in this summary. The country of origin of the data is not specified, but the submitter is Limaca Medical Ltd. from Ein Ha Emeq, Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is typically relevant for studies involving diagnostic accuracy where human interpretation informs the "ground truth." Since the document describes bench and preclinical studies for a biopsy instrument, and not a diagnostic AI device, this information is not applicable and therefore not provided. The performance data focuses on mechanical and functional aspects of the device and its ability to acquire samples, rather than the diagnostic interpretation of those samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this information is specific to human-read diagnostic studies or studies involving agreement among multiple reviewers, which is not the focus of the provided performance data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Precision GI is a biopsy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as the Precision GI is a biopsy instrument and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "Sample Acquisition" assessment in the preclinical study, the ground truth would likely be based on:
- Histopathology/Pathology: Evaluation of the acquired tissue samples to determine quality, diagnostic yield, and preservation, which would be interpreted by pathologists.
- Visual observation/measurement: For aspects like needle deformation, echogenicity, etc., the "ground truth" would be direct measurement or observation against predetermined specifications or comparisons to the predicate device's performance.
The document summary does not explicitly state how "good sample acquisition" was determined (e.g., specific metrics or expert pathology review process).
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train AI/machine learning algorithms. This device is a biopsy instrument, not an AI device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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August 28, 2023
Limaca Medical Ltd % Susan Alpert Regulatory Affairs Consultant SFADC LLC 2425 L Street NW, Apt 307 Washington, District of Columbia 20037
Re: K231422
Trade/Device Name: Precision GI Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Received: July 27, 2023
Dear Susan Alpert:
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
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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 mediation-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,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Precision Gl
Indications for Use (Describe)
Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
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)
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Image /page/3/Picture/0 description: The image shows the logo for LIMACA Medical. The logo is a stylized text design with the word "LIMACA" in a modern font. Below the logo is the text "For Better Endoscopic Biopsies".
510(k) SUMMARY
| Limaca's Precision GI | |
|---|---|
| Submitter: | Limaca Medical Itd. |
| Address | 3 Ha' Rimon Street, |
| Mevo-Carmel Science and Industry Park | |
| 1925000 Ein Ha Emeq Israel | |
| Phone:e-mail: | 972-4-6135050info@limaca-medical.com |
| Contact Person: | Assaf Klein |
| Date Prepared: | 27 July 2023 |
| Name of Device: | Precision GI |
| Common or Usual Name: | Fine needle biopsy |
| Classification Name: | Kit, Needle, biopsy |
| Regulatory Class: | 21 CFR 876.1075, class II |
| Product Code: | FCG |
| Primary Predicate Device: | EndoDrill® Model X biopsy instrument by Bibbinstruments AB(K212423) |
| Reference Device: | EchoTip ProCore HD Ultrasound Biopsy Needle Fine needlebiopsy system, by Cook Medical (K210476) |
Device Description
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope.
The Limaca Precision GI FNB needle is available in one size - 20G.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.
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Image /page/4/Picture/0 description: The image shows the logo for LIMACA Medical. The logo is a stylized text design with a blue accent mark above the letters. Below the logo, the text "For Better Endoscopic Biopsies" is displayed in a simple, sans-serif font.
Intended Use / Indications for Use
The Precision-GI device is intended for use with an ultrasound endoscope (EUS) for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
Comparison of the Technological Characteristic with the Predicate Device
Precision GI is substantially equivalent to other legally marketed biopsy systems including the predicate: EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423)
The Precision GI has the same intended use as its predicate and is used on the same anatomical sites.
The Precision GI device, like its predicate, the EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423), is used in conjunction with an ultrasound endoscope for fine needle biopsy (FNB). Both devices perform tissue acquisition while rotating and advancing electrically. Both the Precision GI device and its predicate use a motor for rotation.
The motor rotation speed of the Precision GI device is 800RPM, while the motor speed of its predicate is higher. The reduced motor speed is safe and yet provides a good sample acquisition as demonstrated in bench tests and preclinical study.
Both devices have an echogenic pattern at the distal end of the needle to allow visualization of the needle tip under endoscopic ultrasound. The Precision GI device, like its predicate, EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423), consists of needle cannula, stylet, sheath and handle.
The needle geometry of the Precision Gl and its predicate is similar. Both have flat circumferential sharpening, however the Precision GI sharpening is internal and the predicate is external. The Precision GI device needle size is 20GA and is made of Nitinol with PTFE coating, while its predicate size is 17GA needle made of Stainless steel. However, there are other FNB needles of different sizes and material, similar to the Precision GI that have been previously approved, such as EchoTip ProCore HD Ultrasound Biopsy Needle Fine needle biopsy system, by Cook Medical (K210476) (Reference device).
Performance Data
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Image /page/5/Picture/1 description: The image shows the logo for Limaca Medical. The logo is a stylized version of the company name, with the letters "LIMA" in a light blue color and the letters "CA" in gray. Below the logo is the text "For Better Endoscopic Biopsi" in a sans-serif font.
The Precision GI device is determined to be substantial equivalent to the predicate device. Engineering bench testing as well as pre clinical study have been performed to support substantial equivalence with the predicate device. Various bench tests as well as pre- clinical data were included in the performance data, including: Dimensional Attributes and EUS compatibility, Shaft insertion/withdrawal force, Stopper lock operation force, Sample Acquisition, Echogenicity, Needle Deformation, Endurance to Distribution Environmental Hazards, Handle resistance force, Extender friction torque, Stylet withdrawal force, Stylet hold-in- position force, Sheath bonding strength, Axial stoper strength, Stylet bonding strength, Handle bending torque durability, Needle bonding torque strength, Tissue wrapping, Needle cyclic loading durability, Needle bonding durability, Needle tissue Penetration force, Needle bonding tensile strength, biocompatibility and sterilization.
Conclusions
The Precision GI is as safe and effective as the EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423). The Precision GI has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Precision GI and its predicate and reference devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Precision GI is as safe and effective as the EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423). Thus, the Precision GI is substantially equivalent to the predicate device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.