(306 days)
Not Found
No
The description focuses on the mechanical aspects of a biopsy instrument and does not mention any AI or ML components or functionalities.
No
This device is intended for obtaining tissue samples for diagnostic purposes, not for treating a condition or disease.
Yes
Explanation: The device is used to obtain histological core samples from soft tissues. These samples are then used to determine the extent of histological abnormality, which is a diagnostic purpose.
No
The device description clearly outlines a physical, disposable biopsy instrument with needles, cannulas, stylets, and mechanical parts, indicating it is a hardware device, not software-only.
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 Semi Automatic Biopsy Instrument is used to obtain a tissue sample from within the body. It is a tool for collecting the specimen, not for analyzing it.
- Intended Use: The intended use clearly states it is for "obtaining percutaneous or surgical histological core samples." This is a procedure to collect tissue, not a diagnostic test performed on a sample.
While the tissue sample obtained by this device may be used for subsequent in vitro diagnostic testing (like histology), the biopsy instrument itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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
KNW
Device Description
The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.
The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing 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, and green= 14G). The needles have a protecting sheath.
The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that 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. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.
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 semi automatic biopsy instrument are 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 tissues such as breast, kidney, liver, lung and various soft tissue masses
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 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.
Sterilization and shelf life of disposable semi automatic biopsy instrument is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 3 years.
Biocompatibility testing of disposable semi automatic biopsy instrument 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 automatic core biopsy instrument concludes that disposable automatic core biopsy instrument is non-toxic and biocompatible.
Performance testing - Bench: The performance of disposable semi automatic biopsy instrument has been verified. Tests as described in table 1 have been completed.
Test Item: Depth projection, Description: To confirm that subject device will not extend over the stylet tip during use. Conformity has been demonstrated.
Test Item: Penetration force, Description: To confirm that the penetration force of the subject device is equivalent to predicate device. Conformity has been demonstrated.
Test Item: Stiffness, Description: To test the stiffness of the refill needle per ISO 9626. Conformity has been demonstrated.
Test Item: Resistance to Breakage, Description: To test the Resistance to Breakage per ISO 9626. Conformity has been demonstrated.
Test Item: Bonding Strength, Description: To test the Bonding Strength per ISO 7864 to confirm the connection firmness. Conformity has been demonstrated.
Test Item: Biopsy Tissue Sample Testing, Description: To confirm that the subject device can successfully retrieve biopsy specimen multiple times. Conformity has been demonstrated.
Test Item: Ultrasound Visibility, Description: 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.
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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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: K212820
Trade/Device Name: Disposable Semi Automatic Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: May 26, 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) K212820
Device Name Disposable Semi Automatic Biopsy Instrument
Indications for Use (Describe)
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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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3
Image /page/3/Picture/0 description: The image contains the logo for Leapmed. The logo consists of the word "LEAPMED" in a serif font, with three curved lines above the "M" to represent radio waves. Below the logo is the text "SUZHOU LEAPMED HEALTHCARE CORPORATION" in a smaller, sans-serif font.
510(k) Summary K212820
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 |
Jul.4, 2022 Date submitted:
2.0 Device Information
| Trade name: | Disposable Semi Automatic Biopsy Instrument |
|---|---|
| Common name: | Biopsy Instrument |
| Classification name: | Gastroenterology-urology biopsy instrument. |
| Model(s): | A, B |
| Production code: | KNW |
| Regulation number: | 21 CFR 876.1075 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
3.0 Predicate Device Information
Manufacturer: M.D.L. S.r.I. Device: SemiCut Semi-automatic Biopsy Needle
4
Image /page/4/Picture/1 description: The image shows the logo for Leapmed, a healthcare corporation based in Suzhou. The text below the logo reads "SUZHOU LEAPMED HEALTHCARE CORPORATION". The 510(k) number is listed as K160316.
4.0 Device Description
The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.
The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing 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, and green= 14G). The needles have a protecting sheath.
The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that 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. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.
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 semi automatic biopsy instrument are 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
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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
5
Image /page/5/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 or a signal. The logo is simple and professional.
SUZHOU LEAPMED HEALTHCARE CORPORATION
(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 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 semi automatic biopsy instrument 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 semi automatic biopsy instrument 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 automatic core biopsy instrument concludes that disposable automatic core biopsy instrument is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of disposable semi automatic biopsy instrument 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 | To confirm that the subject device can successfully |
Table 1: Performance testing summary - Bench
6
Image /page/6/Picture/0 description: The image shows the logo for LeapMed. The logo consists of the word "LEAPMED" in a serif font, with the letters in a dark blue color. Above the "M" in "LEAPMED" are three curved lines, resembling radio waves or a signal. The logo is simple and professional, and the curved lines add a touch of modernity.
K212820
SUZHOU LEAPMED HEALTHCARE CORPORATION
| Testing | 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. |
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. | K212820 | K160316 | |
| Product Code | KNW | KNW | |
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 | |
| Class | II | II | |
| Intended Use | The Disposable Semi Automatic | ||
| Biopsy Instrument is intended for | |||
| obtaining percutaneous or surgical | |||
| histological core samples from soft | |||
| tissues such as breast, kidney, | |||
| liver, lung 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 | SemiCut Semi-Automatic Biopsy | ||
| Needle is intended for obtaining | |||
| percutaneous or surgical | |||
| histological core samples from soft | |||
| tissues such as breast, kidney, | |||
| liver, lung and various soft tissue | |||
| masses. The device is not | |||
| intended for use in bone. | |||
| 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. | |||
| Mechanism of | |||
| Action | Single-hand semi-automatic | ||
| activation | Single-hand semi-automatic | ||
| activation | |||
| Device type | Semi Automatic biopsy gun | Semi Automatic biopsy gun | |
| 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) | 14G,16G,18G,20G | 14G,16G,18G | |
| Needle length | |||
| (mm) | 60,100,130,160,200,250 | 70,90,100,110,120,150,160,200,2 | |
| 50,300 | |||
| Coaxial Needle | |||
| diameter | |||
| (Gauge) | 13G,15G,17G,19G | 13G,15G,17G,19G | |
| Coaxial Needle | |||
| length | |||
| (mm) | 70,78,100,108,130,138,170,178 | 52,53,72,73,82,83,93,132,133, | |
| 143,160,182,183,184,233 | |||
| Color | |||
| Depiction | Per ISO 6009:2016: | ||
| Yellow= 20G, Pink= 18G, Purple= | |||
| 16 G, and Green= 14G | Not publicly available | ||
| 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 20mm | |||
| specimen notch). | |||
| 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 | Single-hand automatic activation | |
| Specimen notch | |||
| size | 10mm,20mm | 10mm,20mm | |
| Penetration | |||
| Depth | 10mm,20mm | 10mm,20mm | |
| 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 | ||
| (ISO10993-4, | |||
| ISO10993-5, | |||
| ISO10993-10, ISO10993-11) | Conform with ISO 10993 | ||
| standards |
Table 2- Comparison of Technology Characteristics
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Image /page/7/Picture/0 description: The image shows the word "LEAPMED" in blue font. Above the "MED" portion of the word, there is a symbol that looks like three curved lines, stacked on top of each other. The font is a serif font, and the overall image is simple and clean.
SUZHOU LEAPMED HEALTHCARE CORPORATION
8
Image /page/8/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. The logo is simple and professional.
K212820
OU 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
- · 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 device needle designs display minor differences between the subject device and the predicate devices for gauge and needle length. The Max Needle gauge 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.