(50 days)
Bone and Bone marrow biopsy devices – Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices – Spring-Cut, Bio-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of histologic 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 histologic 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.
The Sterylab family of biopsy products which include different needles and handles for various procedures. The configurations include manual, semi-automatic and automatic systems. They incorporate various needles styles to optimize capture of the biopsy samples and minimize patient discomfort. The soft tissue devices use a spring-powered mechanism. Some may be used in MRI environments.
The provided text is a 510(k) premarket notification for biopsy devices (needles and instruments). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria that would typically be described with performance metrics.
Therefore, the document does not contain the information requested in the prompt, such as acceptance criteria, reported device performance, study details (sample size, data provenance, expert analysis, adjudication), MRMC studies, standalone performance, or ground truth establishment.
Instead, the document focuses on:
- Device Description: What the devices are (various biopsy needles and handles for manual, semi-automatic, and automatic systems).
- Indications for Use: What the devices are intended for (harvesting bone/bone marrow specimens and providing tissue samples from various soft organs).
- Predicate Devices: Listing similar devices already on the market (MD Tech products).
- Comparison to Predicate Devices: Stating that "There are no significant differences between the proposed devices and the predicates and raise no new safety or efficiency concerns." (This is the core of a 510(k) submission).
- FDA Substantial Equivalence Determination: The FDA's letter confirming that the device is "substantially equivalent" to legally marketed predicate devices.
In summary, this document is a regulatory submission for substantial equivalence, not a clinical study report proving performance against acceptance criteria.
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JUL 27 2005
KORIEOL
Summary of Safety and Effectiveness
Sterylab S.r.l. Via Magenta 77/6 Rho (MI), Italy 20017 Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 3-Jul-05
| Official Contact: | R. Zambelli - President |
|---|---|
| Proprietary or Trade Name: | Bone Biopsy - Ben, Best Liasa, Mielo-CanSoft Tissue Biopsy - Spring-Cut, Bio-Cut, Fast-Gun, Colt |
| Common/Usual Name: | Biopsy needle and needle set, gastro-urologyBiopsy instrument |
| Classification Name: | FCG - Biopsy needle and needle set, gastro-urologyKNW - Biopsy instrument |
| Predicate Devices: | MD TechK980196 - Manan Biopsy Set for Bone and Bone MarrowK974814 - Manan Super Core BiopsyK990839 - Tru-Core 1 Reusable biopsy instrumentK980226 - Manan Pro-Mag Automatic Biopsy system |
Device Description
The Sterylab family of biopsy products which include diffenet needles and handles for various The Steryiau Tanniy of bropsy products manual, semi-automatic and automatic systems. They procedures. The contrigurations movies of the biopsy samplea nd minize patient incorpate various needles styles to optimize captare of consist of a a spring-powered discomion. The son ussue devices use gamestion. Some may be used in MRI environments.
Indications for use
Bone and Bone marrow biopsy devices – Ben, Best Lisas, and Mielo-Can are indicted to narvestion by hopen Bone and / or bone marrow specimens. The pediative bone marrow needle is intentive information information information or for bone and 7 or bone marrow specificils: "The perpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients.
Soft Tissue Devices – Spring-Cut, Bio-Cut, Fast-Gun and Colt are indicated to provide tissue Soft I Issue Devices = Spinig-Cut, Dio Car, raiv Sax, not limited to, biopsies for breast, lung, samples of various soft of gans and tiosate, morating, "
thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of ameral thyroid, ifver, pancheas, spicen, kidneys, and probate, for thating with partial or complete removal of the imaged abnormality.
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 3-Jul-05
Indications for use (continued)
The extent of histologic abnormality cannot be reliably determined from its mammographic The extent of instologic donormanty cannot of the imaged evidence of an abnormality does not appealance. Therefore, the extent of rologic abnormality (e.g., malignancy). When the sampled product the extent of removal of a maises, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Environment of Use
Hospital, Sub-acute Institutions, Physician office, Outpatient settings, and in some cases MRI environments.
| Characteristics | Bone / Bone MarrowBen, Best Liasa, Mielo-Can | Soft TissueSpring-Cut, Bio-Cut | Soft TissueFast-Gun, Colt |
|---|---|---|---|
| Indications for use | Bone marrow biopsy | Various soft organs and tissues, including, but not limited to,biopsies for breast, lung, thyroid, liver, pancreas, spleen,kidneys, and prostate | Various soft organs and tissues, including, but not limited to,biopsies for breast, lung, thyroid, liver, pancreas, spleen,kidneys, and prostate |
| Needle, cannula | Single lumen needle withinternal style that is advancedmanually | Single action needle. Singlelumen needle with internalstylet with guillotine-typeneedle | Dual action needle. Singlelumen needle with internalstylet with guillotine-typeneedle |
| Available sizesneedles, cannulas | Needle / Cannula -7 -18 gauge | Needle / Cannula -14 - 20 gauge | Needle / Cannula -14 - 20 gauge |
| Needleadvancement /penetration depth | Length of needle -9 cm to 15 cmDepth controlled by user bysetting the stopper | Length of needle -90 mm to 470 mmDepth / throw 6, 12, 20 mmpre-set | Length of needle -90 mm to 470 mmDepth / throw 6, 12, 20 mmpre-set |
| Sample notch size | 20 mm | 20 mm | 20 mm |
| Number of samples | One sampleMielo - 2 samples | One sample | One sample |
| Mechanics of action | Manual Spring operated | Manual Spring operated | Manual Spring operated |
| Mode of actionSingle puncture /sample | Single puncture and sample | Single puncture and sample | Single puncture and sample |
| MRI compatibility | No | Yes | Yes |
| Materials in patientcontact | SS AIS 304SS AIS 302 | SS AIS 304SS AIS 302Titanium grade 2 | SS AIS 304SS AIS 302Titanium grade 2 |
General Technical Characteristics
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the proposed devices and the predicates and raise no new safety or effeciaicy concerns.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure with three arms, suggesting support and care. The overall design is simple and conveys the department's mission of promoting health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Sterylab S.R.L. c/o Mr. Paul E. Dryden Regulatory Consultant for Sterylab S.r.l. ProMedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K051506
Trade/Device Name: Sterylab Biopsy devices Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG, KNW Dated: June 04, 2005 Received: June 7, 2005
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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, de rices that hat been that do not require approval of a premarket approval application (PMA). and Oosmeter for ( 100) leat the device, subject to the general controls provisions of the Act. The r ou may, after sy isions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your dovice to such 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 r rease or actived 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set el It Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- c/o Mr. Paul E. Dryden
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w Jourse of substantial equivalence of your device to a legally premance noticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on Jour reporter Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millan
Mark N. Melkerson,MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051506
Sterylab Biopsy devices Device Name: Bone and Bone marrow biopsy devices -Indications For Use: Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices -Spring-Cut, Bio-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of histologic 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 histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures. Over-The-Counter Use AND/OR Prescription Use XX (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mub -ol-Mubara
(Division Sign-Off) Di /ision of General, Restorative and Neurological Devices
510(k) Number K
Page 1 of 1
§ 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.