(306 days)
Not Found
No
The device description and performance testing focus on the mechanical and material properties of a biopsy needle, with no mention of AI or ML capabilities.
No
This device is a biopsy needle used to collect tissue samples for diagnostic purposes. It is not intended to treat or cure a disease or medical condition.
No
Explanation: This device is a biopsy needle, used for collecting tissue samples. While these samples are then used for diagnostic purposes, the needle itself is a tool for specimen collection, not for performing the diagnostic analysis or making a diagnosis.
No
The device description clearly outlines a physical, disposable biopsy needle with various components (stylet, cannula, etc.) and materials (stainless steel). The performance testing focuses on physical properties and functionality of the needle itself, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Biopsy Refill Needle is used to collect a tissue sample from within the body. It is a tool for obtaining the specimen, not for analyzing it.
- Intended Use: The intended use clearly states it's for "soft tissue core biopsy," which is the process of taking a tissue sample.
- Device Description: The description focuses on the physical components and how it's used to acquire the sample (stylet, canula, specimen notch).
- Performance Studies: The performance studies evaluate the physical characteristics of the needle (penetration force, stiffness, resistance to breakage, bonding strength) and its ability to retrieve a sample and be visible under ultrasound. These are not tests related to analyzing a specimen.
While the tissue sample collected by this device will likely be used for in vitro diagnostic testing (histological examination), the device itself is the instrument for obtaining the sample, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes
FCG
Device Description
The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.
The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.
The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Summary of non-clinical and performance testing Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
Study Type: Bench Testing
Sample Size: Not specified, but includes tests for Depth projection, Penetration force, Stiffness, Resistance to Breakage, Bonding Strength, Biopsy Tissue Sample Testing, Ultrasound Visibility.
Key Results:
- Depth projection: Conformity has been demonstrated.
- Penetration force: Conformity has been demonstrated.
- Stiffness: Conformity has been demonstrated.
- Resistance to Breakage: Conformity has been demonstrated.
- Bonding Strength: Conformity has been demonstrated.
- Biopsy Tissue Sample Testing: Conformity has been demonstrated.
- Ultrasound Visibility: Conformity has been demonstrated.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Suzhou Leapmed Healthcare Corporation % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
July 6, 2022
Re: K212819
Trade/Device Name: Disposable Biopsy Refill Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: May 23, 2022 Received: June 6, 2022
Dear Boyle Wang:
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 801); medical
1
device reporting (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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website 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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212819
Device Name Disposable Biopsy Refill Needle
Indications for Use (Describe)
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 Leapmed. The logo consists of the word "LEAPMED" in a serif font, with three curved lines above the "A" in "LEAPMED". Below the logo is the text "SUZHOU LEAPMED HEALTHCARE CORPORATION" in a smaller, sans-serif font.
510(k) Summary K212819
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Suzhou Leapmed Healthcare Corporation |
|---|---|
| Address: | Wuzhong Science Park, NO.2 & NO.3 Building, 38# North Guandu |
| Road, Wuzhong District, Suzhou City, 215100 Jiangsu,P.R.China | |
| Tel: | (+86) 512 66554498-8043 |
| Contact: | Yu Zhu |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 |
| China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date Submitted: Jul.4,2022
2.0 Device Information
| Trade name: | Disposable Biopsy Refill Needle |
|---|---|
| Common name: | Biopsy Needle |
| Classification name: | Gastroenterology-urology biopsy instrument |
| Model(s): | A, B |
| Production code: | FCG |
| Regulation number: | 21 CFR 876.1075 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
3.0 Predicate Device Information
| Manufacturer: | M.D.L. S.r.l. |
|---|---|
| Device: | MDL Biopsy and Coaxial Introducer Needles |
| 510(k) number: | K160316 |
4
4.0 Device Description
The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.
The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.
The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
5.0 Indication for Use Statement
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures
6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1. Results from testing performed confirms that the design requirement
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Image /page/5/Picture/1 description: The image shows the logo for LeapMed. The logo is in blue and features the word "LEAPMED" in a sans-serif font. Above the "MED" portion of the logo are three curved lines, resembling radio waves or a signal. The logo is simple and professional, likely representing a company in the medical or technology field.
SUZHOU LEAPMED HEALTHCARE CORPORATION
specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Disposable Biopsy Refill Needle is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 3 years.
7.2 Biocompatibility testing of Disposable Biopsy Refill Needle has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity and hemolysis. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Biopsy Refill Needle is non-toxic and biocompatible.
7.3 Performance testing - Bench The performance of Disposable Biopsy Refill Needle has been verified. Tests as described in table 1 have been completed.
| Test Item | Description |
|---|---|
| Depth projection | To confirm that subject device will not extend over the stylet tip during use. Conformity has been demonstrated. |
| Penetration force | To confirm that the penetration force of the subject device is equivalent to predicate device. Conformity has been demonstrated. |
| Stiffness | To test the stiffness of the refill needle per ISO 9626. Conformity has been demonstrated. |
| Resistance to Breakage | To test the Resistance to Breakage per ISO 9626. Conformity has been demonstrated. |
| Bonding Strength | To test the Bonding Strength per ISO 7864 to confirm the connection firmness. Conformity has been demonstrated. |
| Biopsy Tissue Sample | |
| Testing | To confirm that the subject device can successfully retrieve biopsy specimen multiple times. Conformity has been demonstrated. Conformity has been demonstrated. |
| Ultrasound Visibility | To confirm that the invasive part of subject device is visible in the area guided by the puncture frame or within the ultrasound range. Conformity has been demonstrated. |
Table 1: Performance testing summary - Bench
7.0 _Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
Table 2- Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K212819 | K160316 |
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Image /page/6/Picture/0 description: The image shows the word "LEAPMED" in blue font. There are three curved lines above the "M" in "LEAPMED", which may be meant to represent radio waves. The font is a serif font.
K212819
SUZHOU LEAPMED HEALTHCARE CORPORATION
| Product Code | FCG | FCG |
|---|---|---|
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Class | II | II |
| Intended | ||
| Use/Indication for | ||
| Use | Disposable Biopsy Refill Needle is | |
| intended for soft tissue core biopsy | ||
| from liver,kidney, prostate, breast, | ||
| spleen, lymph nodes and various | ||
| soft tissue masses. The device is | ||
| not intended for use in bone. | ||
| The extent of histological | ||
| abnormality cannot be reliably | ||
| determined from its | ||
| mammographic appearance. | ||
| Therefore the extent of removal of | ||
| the imaged evidence of an | ||
| abnormality does not predict the | ||
| extent of removal of a histological | ||
| abnormality (e.g. malignancy). | ||
| When the sampled abnormality is | ||
| not histologically benign, it is | ||
| essential that the tissue margins | ||
| be examined for completeness of | ||
| removal using standard surgical | ||
| procedures. | MDL Biopsy Needle is intended for | |
| soft tissue core biopsy with Palium | ||
| Reusable Automatic Biopsy | ||
| Device. The device is not intended | ||
| for use in bone. | ||
| Anatomical sites | Specimens from soft tissue such | |
| as liver, kidney, prostate, breast, | ||
| spleen, lymph nodes and various | ||
| soft tissue masses | Specimens from soft tissue such | |
| as liver,kidney, prostate, breast, | ||
| spleen, lymph nodes and various | ||
| soft tissue masses. | ||
| Mechanism of | ||
| Action | Single-hand automatic activation | one stage or two stage firing |
| mode (user preference) | ||
| Device type | Automatic biopsy gun | Automatic biopsy gun |
| Visualization | Conventional imaging guidance | Conventional imaging guidance |
| technique | equipment excluding MRI | equipment excluding MRI |
| Needle material | Stainless Steel. | |
| Only Stainless steel is in direct | ||
| surgical contact with all soft | ||
| tissues of the patient. | Stainless Steel | |
| Needle diameter | ||
| (Gauge) | 12G,14G,16G,18G,20G | 14G,16G,18G,20G |
| Needle length | ||
| (mm) | 100,130,160,200 | 100,130,150,160,200,250,300 |
| Coaxial | ||
| Needle | ||
| Diameter | 11G,13G,15G,17G,19G | 11G,13G,15G,17G,19G |
| (Gauge) | ||
| Coaxial Needle | ||
| length(mm) | 70,78,100,108,130,138,170,178 | 81,82,111,112,131,133,141,143, |
| 181,183,233,283 | ||
| Cannula and | ||
| Stylet | The cannula is designed with an | |
| outer cutting cannula having a | ||
| sharpened tip and an inner stylet | ||
| with sample slot ( a 19mm | ||
| specimen notch). | The cannula is designed with | |
| an outer cutting cannula having a | ||
| sharpened tip and an inner stylet | ||
| with sample slot( a 20 mm | ||
| specimen notch). | ||
| Color Depiction | Per ISO 6009:2016: | |
| Yellow= 20G, Pink= 18G, Purple= | ||
| 16 G, Green= 14G, Pale | ||
| blue=12G | Not publicly available | |
| Needle | ||
| Advancement | ||
| and Tissue | ||
| Access | Biopsy Needle with guillotine | |
| coring provide the clinician with the | ||
| same single automatic | ||
| advancement for fixed sample | ||
| length for tissue penetration and | ||
| cutting. | Single or two-stage (sequential) | |
| automatic stylet advancement with | ||
| different needle designs | ||
| Activation force | Single-hand automatic activation | Sequential advancement system |
| Specimen notch | ||
| size | 19mm | 20mm |
| Penetration | ||
| Depth | 15mm, 22mm | 15mm,22mm |
| Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide |
| Shelf Life | 3 years | 5 years |
| Single Use | Single Use | Single Use |
| Labeling | Conform with 21 CFR 801 | Conform with 21 CFR 801 |
| Performance | ||
| Comparison | ||
| testing | Comparative test of penetration force, stiffness, resistance to breakage, | |
| bonding strength and depth projection and tissue sample extraction | ||
| testing on the current subject device and the predicate device have | ||
| been performed. | ||
| Biocompatibility | Conform with ISO10993-1 | |
| (ISO10993-4, ISO10993-5, | ||
| ISO10993-10, ISO10993-11) | Conform with ISO 10993 | |
| standards |
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Image /page/7/Picture/0 description: The image shows the logo for LeapMed. The logo is in blue and features the word "LEAPMED" in a serif font. Above the "M" in "LEAPMED" are three curved lines, resembling radio waves.
SUZHOU LEAPMED HEALTHCARE CORPORATION
The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
• Same intended use (The intended use describe is different, but the actual intended use is the same since the predicate device is used with Palium Automatic Reusable
8
K212819
SUZHOU LEAPMED HEALTHCARE CORPORATION
Biopsy Device,and the Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver,kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone.)
- Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology/principal of operation/user interface
The disposable biopsy refill needle designs display minor differences between the subject device and the predicate devices for gauge and needle length,but the comparative performance testing results per FDA recognized standards ISO 9626 and ISO 7864 on the subject device and the predicate device shown there is no significant risk raised by the difference.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K160316 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.