Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm

K203397 · Biopsybell S.R.L. · KNW · Jan 11, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203397
• Device Name: Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
• Applicant: Biopsybell S.R.L.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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

Device Story

Single-use disposable bone marrow aspiration needle; includes cannula, stylet, threaded insert, and rotating spacer. Operation: manual insertion into bone; stylet removal; syringe connection; manual rotation of spacer retracts cannula to collect samples from multiple heights/sites via single puncture. Used in clinical settings by healthcare professionals. Benefits: enables multi-site marrow collection through one puncture, reducing patient trauma.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity), washing process, shelf-life, and mechanical performance (needle retraction, perforation capacity, Luer-lock integrity, sample collection quantity).

Technological Characteristics

Cannula: AISI 304 stainless steel. Syringe: Polycarbonate/ABS/Silicone. Single-use, sterile (Ethylene Oxide). Dimensions: 10 cm length, 11 or 13 gauge. Mechanical operation via threaded insert and rotating spacer for cannula retraction. Biocompatibility compliant with ISO 10993-1.

Indications for Use

Indicated for aspiration or explant of bone marrow in patients requiring bone marrow collection.

Regulatory Classification

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.

Predicate Devices

• Marrow Cellution Bone Marrow Aspiration Needle (K150563)
• Manual-bone-marrow-biopsy-needles, Semi-automatic-biopsy-needles, Automatic-biopsy-needles (K130616)

Reference Devices

• Orion Explant (K130616)
• OSTEOBELL T (K130616)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Pantaleoni<br>Maytal Doo<br>Kneza Miloza 79<br>11000 Beograd (Serbia)<br>Tel. [phone]<br>Mob. [phone]<br>Email: [e-mail] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carlo Ricca Prandi Bellini<br>Biopsybell srl<br>Via A. Manuzio n.24,<br>41037, Mirandola (MO), Italy<br>Telephone: [phone]<br>e-mail: [e-mail] |
| 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 Marrow<br>Aspiration Needle | K150563 |
| BIOPSYBELL | Manual-bone-marrow-biopsy-needles, Semi-<br>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<br>(K150563) | Reference device<br>(K130616) | Reference device<br>(K130616) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------|
| | | | Orion Explant | OSTEOBELL T |
| Device | BONE MARROW MSC<br>ASPIRATION KIT | Marrow Cellution<br>Bone Marrow<br>Aspiration Needle<br>(K150563) | ORION EXPLANT –<br>Needle for bone-<br>marrow explant<br>(K130616) | OSTEOBELL T - Needle<br>for bone-marrow biopsy<br>(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 MARROW<br>MSC ASPIRATION KIT is<br>intended for use for<br>aspiration / explant of<br>bone marrow through a<br>piston syringe. | The Marrow Cellution<br>Bone Marrow<br>Aspiration Needle is<br>intended for use for<br>aspiration<br>of bone marrow or<br>autologous blood<br>using a standard<br>piston syringe. | needle for bone-marrow<br>explant | needle for bone-marrow<br>biopsy |

#### 6. Comparison with the predicate devices

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#### BIOPSYBELL SRL. 510(K) PREMARKET NOTIFICATION - K203397

| | Subject device | Predicate device<br>(K150563) | Reference device<br>(K130616)<br>Orion Explant | Reference device<br>(K130616)<br>OSTEOBELL T |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of Action / Mode of Action | The mechanism of action is bone marrow aspiration / explant.<br>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.<br>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.<br>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.<br>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 gauge<br>10 cm / 13 gauge | 9 cm / 11 gauge<br>11,4 cm / 11 gauge | 11-13-14-15 - gauge<br><br>Every gauge diameter is available in the following dimensions: 7, 9, 11, 13 cm | 7-8-9-11-13 gauge<br><br>Every 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 /<br>Silicone | N/A | N/A | N/A |
| Biocompatibility | | | | |
| Standard | Compliant to ISO 10993-1: | Compliant to ISO 10993-1: | Cytotoxicity<br>Intracutaneous<br>reactivity | Cytotoxicity<br>Intracutaneous<br>reactivity |
| 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.