HS NOTA

K131925 · H.S. Hospital Services S.P.A. · FCG · Oct 10, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K131925
• Device Name: HS NOTA
• Applicant: H.S. Hospital Services S.P.A.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Oct 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Indications for Use

HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver. The device is for prescription use, to be used by physicians in hospitals and clinics.

Device Story

HS NOTA is an automatic, spring-loaded biopsy needle for soft tissue sampling (prostate, kidney, breast, liver). Operated by physicians in hospitals/clinics under fluoroscopic, CT, or mammographic guidance. Device utilizes TRU-CUT methodology; physician manually loads internal springs via a rotating charging lever on the external housing; safety element prevents accidental firing. Upon activation, the needle advances to penetrate tissue and collect a core sample via a 20mm notch on the stylet. Output is a tissue core for diagnostic evaluation. Benefits include standardized, automated sample collection with consistent penetration depth. Device is single-patient use, disposable, and sterile.

Clinical Evidence

Bench testing only. Performance evaluated using bovine liver (low density), bovine scrotum (high density/fibrotic), pork lard, and bovine fat. Testing confirmed successful needle advancement, penetration, and mechanical integrity over multiple firings. Results demonstrated consistent core sample quality and length across all tissue types, confirming performance equivalent to the PRECISA predicate.

Technological Characteristics

Automatic biopsy needle; 304 stainless steel cannula/stylet; nylon external handle; spring-actuated firing mechanism. Available in 14G, 16G, 18G, and 20G diameters; lengths 7-25 cm. Single-patient use, sterile, non-pyrogenic. Operates via manual spring loading and trigger release. No electronic or software components.

Indications for Use

Indicated for use in fluoroscopic, CT, and mammographic procedures to obtain soft tissue biopsies (prostate, kidney, breast, liver) in patients requiring such diagnostic sampling. Prescription use only by physicians in clinical settings.

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

• PRECISA biopsy needle (K002944)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right. The profiles are stylized and appear to be made of flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

H.S. Hospital Services S.p.A. Mr. Lucio Improta General Manager Via A. Vacchi, 24/26 04011 Aprilia LT, ITALY

Re: K131925

Trade/Device Name: HS NOTA Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: September 25, 2014 Received: September 29, 2014

Dear Mr. Improta:

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. 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 device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.10 13:08:15 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131925

Device Name HS NOTA

Indications for Use (Describe)

HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver.

The device is for prescription use, to be used by physicians in hospitals and clinics.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows a logo with the letters 'HS' in a stylized, connected font. The letters are teal in color. A small registered trademark symbol is located to the upper right of the 'S'.

# 5. 510(k) Summary

# 1. Submitter Information

| Owner: | H.S. Hospital Service S.p.A.<br>Via A. Vacchi, 24/26<br>04011 Aprilia (LT) – Italy<br>tel.: [phone] - fax: [phone] |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | US representative<br>H-S Medical, Inc.<br>Mr. Lucio Improta<br>6600 W. Rogers Circle – Suite 1 & 2<br>Boca Raton, FL 33487<br>Tel.: [phone] - Fax: [phone]<br>email: [e-mail] |
| Date summary prepared: | October, 07 2014 |

# 2. Name of Device

| Trade or Proprietary Name: | HS NOTA |
|-------------------------------------------------------------------|---------------------------------------------------------------------|
| Common or Usual Name: | Biopsy needle |
| Regulation Name:<br>Product code:<br>Regulation number:<br>Class: | Gastroenterology-urology biopsy instrument<br>FCG<br>876.1075<br>II |

# 3. Predicate device:

The HS Nota is substantially equivalent to the following legally marketed device:

- HS Hospital Service S.p.A. "PRECISA" biopsy needle cleared and marketed under . K002944.
# 4. Intended use

HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver. The device is for prescription use, to be used by physicians in hospitals and clinics.

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Image /page/4/Picture/0 description: The image shows a logo with the letters 'HS' in a teal color. The letters are stylized and connected, with the 'H' being slightly larger than the 'S'. A registered trademark symbol (®) is located in the upper right corner of the 'S'.

Equivalently, the predicate device is an automated disposable and adjustable biopsy needle to be used in fluoroscopic CT and mammographic procedures to obtain biopsies of various tissues including those from prostate, kidney, breast and liver (soft tissues). Also, the predicate device is for prescription use, to be used by physicians in hospitals and clinics

### 5. Functioning

Both HS NOTA and the predicate device are based on the TRU-CUT methodology (also known as modified Vim-Silverman technique) to obtain biopsies of soft tissues.

### 6. Device description

Both the HS NOTA and the predicate device consist of a 304 stainless steel cannula and stylet. In both the devices the cannula and stylet inner handles are moved by springs that must be loaded, toward a charging lever positioned on the external housing of the needle, before firing the needle.

Both PRECISA and HS NOTA are single patient use, disposable, sterile and non-pyroqenic products.

The external plastic handle of HS NOTA has a different shape relative to the predicate device. This difference does not affect the performance or safety of the device as it does not affect the advancement and penetration of the needle inside the tissues, yet it just implies a different way for the user to handle the device.

The charging lever for PRECISA needle is straight, it means operator must pull-it for charging, while the NOTA one is designed to be rotated for loading the springs. This difference is a consequence of the specific external plastic handles of HS NOTA relative to the predicate device and does not impact in safety and effectiveness of the needles.

HS NOTA needle performs a biopsy of 2.5 cm of length inside the soft tissue. PRECISA needle can be adjusted to advance 1 cm or 2 cm of length. When considering PRECISA needle in 2 cm advancing configuration there is a total equivalence between the two devices. Indeed the additional run of 0.5 cm characterizing HS NOTA, is only due to the different inner mechanism of the HS NOTA compared to PRECISA and it does not affect safety and effectiveness: final outcomes in terms of quality and length of the bioptic samples depend on the notch realized on the stylet (shape of stylet tip) which is exactly the same for both HS NOTA and PRECISA.

The sample notch size is 20 mm. So maximum length for core collected is 20 mm.

The shape of cannula and stylet tips are exactly the same for HS NOTA and PRECISA. It means that the HS NOTA and PRECISA are substantially equivalent as capacity to cut the soft tissue.

| H.S. Hospital Service S.p.A. |
|---------------------------------------------------------------|
| Via A. Vacchi 24/26 - 04011 Aprilia (LT) - Italy |
| tel.: [phone] - fax: [phone] |

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'HS' in a stylized, interconnected design. The letters are rendered in a teal or dark cyan color. The 'H' is a blocky, sans-serif letter, while the 'S' is more curved and flowing, with the top of the 'S' connecting to the right side of the 'H'. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

The Spring used inside the two devices are exactly the same, it means that the force moving the cannula and stylet of both the needle is exactly the same.

Needles diameter characterizing both HS NOTA and PRECISA are 14G, 16G, 18G, and 20G. Furthermore both the devices are provided with needles characterizing by a length within the range 7 cm-25 cm.

HS NOTA is provided with a safety element that is automatically activated as the spring has been loaded. The safety feature must be removed by the physician to fire the device. This mechanism allows to avoid accidental firing of the needle. The predicate device has been manufactured with an identical safety element.

Inner mechanism: The inner mechanism for an automatic biopsy device is responsible for the automatic movements of both stylet and cannula composing the needle. The inner mechanism of HS NOTA is composed by:

- 1. 2 plastic handles, each plastic handle is attached to stylet and cannula distal part, both these handles slide inside the external plastic housing of the product, each plastic handle is provided with hooking means capable to retain the handle in charged position once the spring has been charged
- 2. Inner spring that must charged, they are responsible for the automatic advancing of the inner plastic handles.
- 3. A firing lever which is capable to pull back the inner plastic handles (loading the sprinq) during the charging phase and which is capable to act on the hooking means (which are part of the inner plastic handles) realising them and making possible the inner handles advancing.

PRECISA inner mechanism is composed by the same functional elements.

During the functioning of the product no mechanical damages on these parts must occur.

### Materials:

The only part of HS NOTA coming in contact with the patient is represented by the cannula and stylet that are made of biocompatible AISI 304 material, identically to the predicate device. The external part of the device representing the plastic handle is made of nylon while PRECISA's plastic handle is made of ABS. This difference does not affect effectiveness and safety of the device since both nylon and ABS have equivalent characteristics: they are thermoplastic materials allowing the needle to move properly and providing adequate resistance to the force exerted by the spring on the device.

### Performance test

HS NOTA was tested according to the Guidance for the Content of Premarket Notifications for Biopsy Device used in gastroenterology and urology (Section XI),

Especially two identical tests were performed considering different samples:

1) The first test was performed on bovine liver (loose and a low density tissue) and bovine scrotum (very fibrotic and a high density tissue) representing the worst cases conditions.

| H.S. Hospital Service S.p.A. |
|---------------------------------------------------------------|
| Via A. Vacchi 24/26 - 04011 Aprilia (LT) - Italy |
| tel.: [phone] - fax: [phone] |

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Image /page/6/Picture/1 description: The image shows a logo with the letters 'HS' in a stylized, teal-green font. The 'H' is a blocky, sans-serif letter, while the 'S' is more curved and flowing. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the 'S'.

The results of the test demonstrate good needle advancement and penetration and give evidence that the device is capable of being fired and is able to obtain the claimed (20) amount of samples without damage to the interior mechanism, and that the quality and size of the biopsy sample taken with the later shots are equivalent for the type of tissues for which the device is indicated.

This kind of test represents a HS HOSPITAL SERVICE standard for all the marketed automatic biopsy needles. It means that the same functional test was performed on the "PRECISA" needle and gave equivalent results.

2) The second test was performed considering pork lard and bovine fat as they have intermediate characteristics compared to the boundary considered in test 1, in term of consistence, density and hardness that are the characteristics affecting the performance of the device. Overall the results obtained with this second test confirm good needle advancement and penetration with no damages to the interior mechanism nor in the cores and again, the devise was able to obtain the claimed (20) amount of samples. Also, the core length obtained using the fat samples are in line with those obtained when HS NOTA performance was tested on the bovine liver and scrotum (test 1). Specifically the averaged core length of biopsies from fat samples gave values that are higher than the values obtained on the bovine scrotum (a more fibrotic and denser tissue) but lower that those measured on the bovine liver (characterized by poor consistence and density).

Therefore, the fat samples fall within the range of the identified boundary conditions (scrotum and liver tissues) further corroborating the effectiveness and safety of the subject device.

In conclusion the performance tests demonstrate that the HS NOTA devise is as safe, as effective, and performs at least as well as the legally marketed predicate device HS PRECISA.