(306 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable biopsy needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: A therapeutic device is used for treating or curing a disease. This device is a biopsy needle, used for obtaining tissue samples for diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section states: "Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures." The "Device Description" section further clarifies its role: "...obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment." Taking biopsy samples for "clinical diagnosis" is a diagnostic function.
No
The device description clearly outlines a physical, disposable biopsy needle with various components and materials, intended for use in soft tissue biopsy procedures. It undergoes bench testing for physical properties and sterilization validation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a biopsy needle. Its purpose is to obtain a tissue sample from the body. It is a tool used during a medical procedure to collect the specimen.
- Intended Use: The intended use clearly states it's for "soft tissue core biopsy procedures" to "obtain biopsy samples... for clinical diagnosis or treatment." This describes the collection of the sample, not the analysis of the sample.
- Lack of Analysis: The description focuses on the physical characteristics of the needle, its materials, and how it facilitates the collection process. There is no mention of any component or function that analyzes the collected tissue sample.
While the tissue sample obtained using this needle will likely be used for in vitro diagnostic testing later, the needle itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.
Product codes
FCG
Device Description
The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths.
The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula.
The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface.
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
Conventional imaging guidance equipment excluding MRI (Ultrasound Visibility mentioned in performance testing)
Anatomical Site
soft tissue
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
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 7864, 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.
Summary of bench tests:
- Depth projection: To confirm that subject device will not extend over the stylet tip (over-throw) 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.
- Mechanical durability: To confirm that subject device withstands the forces applied to the subject device during normal use. 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.
- Qualification metal tubing/needle component: The stainless-steel tubing fulfills the requirement in ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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
Re: K212822
Trade/Device Name: Disposable Coaxial Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: May 27, 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
July 6, 2022
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) K212822
Device Name Disposable Coaxial Biopsy Needle
Indications for Use (Describe)
Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.
| 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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3
510(k) Summary K212822
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: | |
| Email: | +86-21-50313932 |
| Info@truthful.com.cn |
Date of Preparation: Jul.4,2022
2.0 Device Information
| Trade name: | Disposable Coaxial Biopsy Needle |
|---|---|
| Common name: | Biopsy Needle |
| Classification name: | Gastroenterology-urology biopsy instrument |
| Model(s): | 11G、13G、15G、17G、19G |
| 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 INTRO Coaxial Introducer Needles |
| 510(k) number: | K160316 |
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4.0 Device Description
The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths.
The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula.
The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface.
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 Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.
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 7864, 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.
7.1 Sterilization and shelf life disposable coaxial biopsy needle is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 3 years.
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7.2 Biocompatibility testing of disposable coaxial biopsy needle has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable coaxial biopsy needle is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of disposable coaxial biopsy 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 (over-throw) 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. |
| Mechanical durability | To confirm that subject device withstands the forces applied to the subject device during normal use. 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. |
| Qualification metal tubing/needle component | The stainless-steel tubing fulfills the requirement in ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. 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
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K212822 | K160316 |
| Product Code | FCG | FCG |
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Class | II | II |
| Intended Use | Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue | Coaxial Introducer Needle is intended for use with biopsy devices cannula during soft tissue |
| core biopsy procedures. The | ||
| device is not intended for use in | ||
| bone. | core biopsy procedures. The | |
| device is not intended for use in | ||
| bone. | ||
| The extent of histological | ||
| abnormality cannot be reliably | ||
| determined from it 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. | ||
| Anatomical | ||
| sites | Specimens from soft tissue such | |
| as breast, kidney, liver, lung and | ||
| various soft tissue masses | Specimens from soft tissue such | |
| as breast, kidney, liver, lung and | ||
| various soft tissue masses. | ||
| Device type | Coaxial introducer needle with a | |
| blunt tip stylet | Coaxial introducer needle with a | |
| blunt tip stylet | ||
| Visualization | ||
| technique | Conventional imaging guidance | |
| equipment excluding MRI | Conventional imaging guidance | |
| 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) | 11G,13G,15G,17G,19G | 13G,15G,17G,19G |
| Needle length | ||
| (mm) | 70、78、100、108、130、138、 | |
| 170、178 | 90,132,170,217 | |
| Cannula and | ||
| Stylet | The cannula is designed with an | |
| outer cutting cannula having a | ||
| sharpened tip and an inner stylet | ||
| with sharping or without sharping. | The cannula is designed with an | |
| outer cutting cannula having a | ||
| sharpened tip and an inner stylet | ||
| with sharping or without sharping. | ||
| 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 on the current subject device and the predicate device has been performed. | |
| Biocompatibility | Conform with ISO10993-1 | |
| (ISO10993-4, ISO10993-5, | ||
| ISO10993-10, ISO10993-11) | Conform with ISO 10993 standards |
Table 2- Comparison of Technology Characteristics
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510(k) Summary
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
- · Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology
The Disposable Coaxial Biopsy Needle designs display minor differences between the subject device and the predicate devices for needle length. The Max Needle length of the current device are bigger than those of the predicate device, 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.