The BONE MARROW MSC ASPIRATION KIT is a single use disposable needle intended for the aspiration / explant of bone marrow. The structure of BONE MARROW MSC ASPIRATION KIT device includes a cannula with a stylet inside, with a threaded insert and a rotating spacer that allow the precise retraction of the cannula to a determined length. Once the cannula has been inserted and positioned, the stylet can be removed and a syringe is connected to execute the aspiration. By manually rotating the rotating spacer, the cannula retracts, raising inside the bone marrow, in order to be able to perform aspiration / explant from fresh sites at different heights.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "BONE MARROW MSC ASPIRATION KIT". This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, meaning they generally do not require extensive de novo clinical studies to prove effectiveness in the same way a new drug or novel medical device might. The document focuses on demonstrating substantial equivalence rather than presenting a detailed study proving device meets specific clinical acceptance criteria in a comparative effectiveness study with human readers or standalone performance.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC study effect size, type of ground truth for test and training sets) are not typically included in a 510(k) for a device like a bone marrow aspiration kit, as the primary evidence provided is performance data from design verification and validation testing, and comparison to predicate devices, rather than clinical efficacy data.

Here's a breakdown of the information that can be extracted and what is not available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in a single, clear format for clinical outcomes. Instead, it lists performance/functionality/safety tests and states that the "Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use."

However, we can infer some criteria from the tests performed:

Acceptance Criteria (Inferred from tests)	Reported Device Performance
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Material mediated pyrogenicity, Acute systemic toxicity)	Compliant to ISO 10993-1. (Results demonstrate meeting safety and performance requirements)
Efficacy of Needle retraction	Met requirements
Excursion of the Needle threaded insert	Met requirements
Maximum useful length of the needle cannula	Met requirements
Adequacy of the Needle aspiration surface	Met requirements
Needle handle Grip during bone insertion procedures	Met requirements
Needle perforation capacity in the bone	Met requirements
Adequacy of the Needle Luer-Lock Connection	Met requirements
Quantity of bone marrow sample collected by the needle	Met requirements
Integrity of the aspiration syringe	Met requirements
EO Sterilization Validation	Met requirements
Washing Process Verification	Met requirements
Packaging shelf life accelerated aging tests	Met requirements

2. Sample size used for the test set and the data provenance

The document does not provide details on sample sizes for each test listed under "Performance Data." These are typically engineering and laboratory verification and validation tests, not clinical trials with human subjects. Thus, information on "country of origin of the data" or "retrospective or prospective" is not applicable in the context of these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance data presented are from technical/engineering tests, not clinical evaluations requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set

Not applicable. This typically refers to resolving discrepancies in expert interpretations in clinical studies, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a bone marrow aspiration kit, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document indicates "Performance Data" obtained through various engineering and functional tests (e.g., biocompatibility testing, mechanical performance testing, sterilization validation). The "ground truth" for these types of tests would be adherence to established engineering standards, material specifications, and regulatory requirements (e.g., ISO 10993 for biocompatibility). There is no "expert consensus, pathology, or outcomes data" mentioned in the context of establishing ground truth for these device performance tests.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a physical device and not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

January 11, 2021

Biopsybell s.r.l. % Maurizio Pantaleoni Senior Consultant Maytal Doo Kneza Milosa, 79 Belgrade, Serbia 11000 Serbia

Re: K203397

Trade/Device Name: BONE MARROW MSC ASPIRATION KIT Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: November 6, 2020 Received: November 18, 2020

Dear Maurizio Pantaleoni:

We have reviewed your Section 5100k) 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

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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 and Part 809); medical 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-devices/medical-device-reportingmdr-how-report-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 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,

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

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Indications for Use

510(k) Number (if known) K203397

Device Name BONE MARROW MSC ASPIRATION KIT

Indications for Use (Describe)

The BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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BIOPSYBELL SRL.

510(K) PREMARKET NOTIFICATION - K203397

1. General Information
  Submitter :

Biopsybell srl is located at: Via A. Manuzio n.24 41037, Mirandola (MO) ITALY

Establishment Registration Number: 9617616

Contact:	Maurizio PantaleoniMaytal DooKneza Miloza 7911000 Beograd (Serbia)Tel. +381 11 3340700Mob. +39 3484435155Email: regulatory@maytal.eu
Contact:	Carlo Ricca Prandi BelliniBiopsybell srlVia A. Manuzio n.24,41037, Mirandola (MO), ItalyTelephone: +39 0535 27850e-mail: qara@biopsybell.it
Summary Preparation Date:	January 06th, 2021

2. Name & Classification

Device Name:	BONE MARROW MSC ASPIRATION KIT
Common Name:	Bone Marrow Biopsy Needle
Regulation Name:	Gastroenterology-urology biopsy instrument
Regulation Number:	876.1075
Product Code:	KNW
CLASS:	II

3. Predicate Devices

The BONE MARROW MSC ASPIRATION KIT is substantially equivalent to the following devices:

Applicant	Device name	510(k) Number
RANFAC	Marrow Cellution Bone MarrowAspiration Needle	K150563
BIOPSYBELL	Manual-bone-marrow-biopsy-needles, Semi-automatic-biopsy-needles, Automatic-biopsy-needles	K130616

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BIOPSYBELL SRL.

510(K) PREMARKET NOTIFICATION - K203397

4. Indications for Use

The BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.

5. Device Description

The BONE MARROW MSC ASPIRATION KIT is a single use disposable needle intended for the aspiration / explant of bone marrow.

The structure of BONE MARROW MSC ASPIRATION KIT device includes a cannula with a stylet inside, with a threaded insert and a rotating spacer that allow the precise retraction of the cannula to a determined length.

Once the cannula has been inserted and positioned, the stylet can be removed and a syringe is connected to execute the aspiration.

By manually rotating the rotating spacer, the cannula retracts, raising inside the bone marrow, in order to be able to perform aspiration / explant from fresh sites at different heights.

	Subject device	Predicate device(K150563)	Reference device(K130616)	Reference device(K130616)
			Orion Explant	OSTEOBELL T
Device	BONE MARROW MSCASPIRATION KIT	Marrow CellutionBone MarrowAspiration Needle(K150563)	ORION EXPLANT –Needle for bone-marrow explant(K130616)	OSTEOBELL T - Needlefor bone-marrow biopsy(K130616)
510(K) number	-
Applicant	BIOSPYBELL S.R.L.	RANFAC	BIOPSYBELL S.R.L.	BIOPSYBELL S.R.L.
Classification
Reg. Number	876.1075	876.1075	876.1075	876.1075
Product Code	KNW	KNW	KNW	KNW
Regulatory Class	II	II	II	II
Intended use
Intended use	The BONE MARROWMSC ASPIRATION KIT isintended for use foraspiration / explant ofbone marrow through apiston syringe.	The Marrow CellutionBone MarrowAspiration Needle isintended for use foraspirationof bone marrow orautologous bloodusing a standardpiston syringe.	needle for bone-marrowexplant	needle for bone-marrowbiopsy

6. Comparison with the predicate devices

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BIOPSYBELL SRL. 510(K) PREMARKET NOTIFICATION - K203397

	Subject device	Predicate device(K150563)	Reference device(K130616)Orion Explant	Reference device(K130616)OSTEOBELL T
Mechanism of Action / Mode of Action	The mechanism of action is bone marrow aspiration / explant.The needle is placed manually, then with a single puncture, is possible to collect bone marrow samples at different heights through the rotation of the rotating spacer.	The mechanism of action is bone marrow aspiration / explant.The needle is placed manually, then with a single puncture, is possible to collect bone marrow samples at different heights through the rotation of the ring nut.	The mechanism of action is bone marrow aspiration / explant.The needle is placed manually, then with a single puncture, is possible to collect bone marrow samples at different heights through the rotation of the ring nut.	The mechanism of action is bone marrow biopsy.The needle is placed manually, then with a single puncture, is possible to collect bone marrow samples.
Design Features
Single Use Device	YES	YES	YES	YES
Dimensions of cannula (length / gauge)	10 cm / 11 gauge10 cm / 13 gauge	9 cm / 11 gauge11,4 cm / 11 gauge	11-13-14-15 - gaugeEvery gauge diameter is available in the following dimensions: 7, 9, 11, 13 cm	7-8-9-11-13 gaugeEvery gauge diameter is available in the following dimensions: 10, 15 cm
Materials
Cannula	AISI 304 stainless steel	Stainless steel	AISI 304 stainless steel	AISI 304 stainless steel
Syringe	Polycarbonate / ABS /Silicone	N/A	N/A	N/A
Biocompatibility
Standard	Compliant to ISO 10993-1:	Compliant to ISO 10993-1:	CytotoxicityIntracutaneousreactivity	CytotoxicityIntracutaneousreactivity
Sterilization
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

7. Performance Data

A program of design verification and validation testing was performed that includes the following:

. Biocompatibility; the following biocompatibility tests have been performed:
- o Cytotoxicity
- o Sensitization
- Irritation or intracutaneous reactivity o
- o Material mediated pyrogenicity
- o Acute systemic toxicity
. Verification of Washing Process
. Packaging shelf life accelerated aging tests
Performance/Functionality/Safety; the following tests have been performed:
- o Needle retraction efficacy
- Excursion of the Needle threaded insert O
- O Maximum useful length of the needle cannula
- o Needle aspiration surface
- o Needle handle Grip during bone insertion procedures
- Needle perforation capacity in the bone o
- o Adequacy of the Needle Luer-Lock Connection

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o Quantity of bone marrow sample collected by the needle
o Integrity of the aspiration syringe
EO Sterilization Validation

Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use.

8. Clinical data

N/A

9. Conclusions

In light of evidences summarized above and based on classification, intended use, technological characteristics and performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

Regulation Number and Section

§ 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.