(103 days)
No
The summary describes a mechanical, motorized biopsy device and does not mention any AI or ML components or functionalities. The performance studies focus on mechanical and material properties, not algorithmic performance.
No.
This device is used for fine needle biopsies (FNB), which is a diagnostic procedure to collect tissue samples, not a therapeutic intervention.
Yes
The device is used for fine needle biopsies, which are procedures that collect tissue samples for diagnostic purposes.
No
The device description explicitly states it is a "motorized, automated, rotational, cutting EUS-Biopsy needle" and a "battery-operated, motorized, automated rotational cutting biopsy device," indicating it is a physical hardware device with mechanical and electrical components, not solely software.
Based on the provided information, the Precision GI device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fine needle biopsy (FNB) of various lesions and masses. This is a procedure to obtain a tissue sample from the body.
- Device Description: The device is a biopsy needle used to collect tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
The Precision GI device is used within the body to collect the sample, not to perform a diagnostic test on a sample that has already been collected. The diagnostic testing would be performed on the tissue sample obtained by the Precision GI device, but the device itself is the tool for sample collection, not the diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound endoscope (EUS)
Anatomical Site
submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / Not Found
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)
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.
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.
EndoDrill® Model X biopsy instrument by Bibbinstruments AB (K212423)
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.
EchoTip ProCore HD Ultrasound Biopsy Needle Fine needle biopsy system, by Cook Medical (K210476)
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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 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
2
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: | 972-4-6135050 |
| info@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 needle |
| biopsy 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.