(68 days)
No
The device description and intended use clearly describe a purely mechanical insufflation device for manual operation, with no mention of computational or data-driven components.
No.
The device itself is not a therapeutic device, but rather a delivery system for a therapeutic substance (medical grade talc) used in pleurodesis. It facilitates the administration of the therapy, but it does not exert a therapeutic effect on its own.
No
The device is described as a "powder blower" intended for the manual insufflation of medical-grade talc. Its function is to administer a substance into the body, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like polypropylene, polyethylene, Soft-PVC, and polycarbonate, indicating it is a hardware device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the manual insufflation of medical grade talc into the pleurodesis. This is a procedure performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is a powder blower designed to deliver a substance (talc) into a body cavity (pleural cavity).
- Anatomical Site: The device is introduced into the pleural cavity.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for a therapeutic procedure performed directly on a patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
Product codes
GCJ
Device Description
NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial.
The device is a sterile, single use medical device which is sterilized by gamma sterilization.
The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started.
The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Introduced into the pleural cavity.
Indicated Patient Age Range
Adults diagnosed with any of the indications approved for the medical grade talc that requires manual insufflation of medical grade talc into the pleural cavity during pleurodesis.
Intended User / Care Setting
Physicians with experience in pleurodesis in cooperation with trained staff / Hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing: Assessment of biological risks following EN ISO 10993-1:2009. The device is classified as "external communicating device" with "limited" (
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2017
NOVATECH S.A. % Mr. Stuart K. Montgomery President Boston Medical Products Inc. 70 Chestnut Street Shrewsbury, Massachusetts 01545
Re: K170030
Trade/Device Name: NOVATECH TALCAIR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 2, 2017 Received: January 4, 2017
Dear Mr. Montgomery:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
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For 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
2
Indications for Use
510(k) Number (if known) K170030
Device Name NOVATECH® TALCAIR™
Indications for Use (Describe)
The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
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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510(K) SUMMARY
1 SUBMITTER
NOVATECH S.A. Z.I. Athélia III - 1058, Voie Antiope 13705 La Ciotat CEDEX FRANCE
Ph: +33 (0) 442 98 15 63 Fax: +33 (0) 442 98 15 63
Contact Person(s)
Dr. Jennifer Neff Director Regulatory & Medical Affairs
Stuart K. Montgomery President Boston Medical Products Inc. 70 Chestnut Street Shrewsbury, MA 01545, USA
Ph: 508-898-9300 ext. 240 Fax: 508-898-2373
Date Prepared
January 2, 2017
2 Device
| Trade Name: | NOVATECH® TALCAIR™ |
|---|---|
| Common Name: | Powder Blower |
| Device Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulation Number and Description: | 876.1500 Endoscope and accessories |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GCJ |
| Device Class: | 2 |
3 Predicate Device
| Device Name: | NOVATECH® TALCAIR™ |
|---|---|
| Original Applicant: | Novatech S.A. |
| 510(k) Number: | K151832 |
| Product Code/Regulation Number: | GCJ/876.1500 Endoscope and Accessories |
4
No reference devices were used in this submission.
NOVATECH® TALCAIR™ (510(k) number - K151832) is approved for the indication: "Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid". NOVATECH S.A. is submitting this 510(k) notification to add that the device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
In addition, NOVATECH S.A. is using NOVATECH® TALCAIR™ (approved under K151832) as a predicate device for this submission. The device remains exactly the same with only the addition of a new indication.
4 Device Description
NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial.
The device is a sterile, single use medical device which is sterilized by gamma sterilization.
The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started.
The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
5 Indication for Use
The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
6 Comparison of technological characteristics with the predicate device
The NOVATECH® TALCAIR™ has the same operating principle and incorporates the same basic design as the predicate device, the NOVATECH® TALCAIR™. A summary
5
of the technological characteristics of NOVATECH® TALCAIR™ compared to NOVATECH® TALCAIR™ is provided below.
| Item | Proposed Device:
NOVATECH® TALCAIR™ | Predicate Device:
NOVATECH® TALCAIR™ |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GCJ | Same |
| Regulation Number | 876.1500 | Same |
| Class | 2 | Same |
| Intended Use | The device is intended for manual
insufflation of medical grade talc
into the pleural cavity during
pleurodesis. The device is indicated
for use according to the approved
indication for use of the medical
grade talc. | Administration of medical grade
talc via thoracoscopy. The device
is intended to treat patients with
malignant pleural effusion. |
| Indication for Use | The device is intended for manual
insufflation of medical grade talc
into the pleural cavity during
pleurodesis. The device is indicated
for use according to the approved
indication for use of the medical
grade talc. | Treatment of malignant pleural
effusion by insufflation of
medical grade talc following
drainage of pleural fluid. |
| Patient Population | Adults diagnosed with any of the
indications approved for the
medical grade talc that requires
manual insufflation of medical
grade talc into the pleural cavity
during pleurodesis. | Those diagnosed with malignant
pleural effusion. |
| Anatomical Sites | Introduced into the pleural cavity. | Same |
| Environmental of Use | Hospital | Same |
| Energy used and / or
delivered | Air insufflation occurs by the
manually operated rubber bulb. | Same |
| Principal Operator | Physicians with experience in
pleurodesis in cooperation with
trained staff | Same |
| Design | Powder Blower comprising an
insufflation cannula with an
attached vial coupling, and a
separate insufflation bulb.
The semi-rigid insufflation cannula
has an effective length of about
16.5 inches (42 cm) at an outer
diameter of 0.118 inches (3 mm). | Same |
| | The attached vial coupling is used
to snap-fit the vial. | |
| | The separate insufflation bulb has
two valves controlling the one-way
direction of airflow. Insufflation
bulb and vial coupling are
connected by luer connectors
before device use. | |
| Materials | PVC, Polyethylene, Polycarbonate | Same |
| Principles of
Operation | The NOVATECH® TALCAIR™
vial coupling is inserted into the
vial by pressing the vial coupling
onto the vial. The insufflation bulb
is then attached to the vial coupling. | Same |
| Sterilization | NOVATECH® TALCAIR™ is a
single use product and is supplied
sterile.
Instructions for sterilization and re-
sterilization/re-use of the product
are unnecessary.
Therefore, effectiveness of any kind
of reuse and reprocessing has not
been demonstrated. | Same |
| Sterility | NOVATECH® TALCAIR™ is
supplied sterile and is intended for
single use according to the
sterilization validation of the
product. | Same |
| Shelf Life | 5 years | Same |
Tabular Comparison to Predicate Device
6
7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The assessment of biological risks, the procedures and provisions of EN ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process 2 (including Technical Corrigendum 1, published on 15 June 2010), as well as Blue Book Memorandum G 95-1 / FDA Draft Guidance dated
7
April 23, 2013 "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were applied.
NOVATECH® TALCAIR™ is biological classified "external communicating device" with "limited" (