(85 days)
Not Found
No
The device description focuses on a physical accessory for brachytherapy, and there are no mentions of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is an accessory used in brachytherapy procedures, designed to prevent the intrauterine tube from being inserted too deeply. It doesn't directly treat or cure a disease; rather, it facilitates the therapeutic procedure.
No
The device description indicates that the Smit Sleeve is an accessory used for Intracavitary Brachytherapy procedures, specifically designed to aid in the delivery of radiation therapy by preventing the Gynaecological Applicator from being inserted too deeply into the Uterus and allowing for multiple insertions without cervical dilation. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly describes a physical accessory (Smit Sleeve) made of materials and used in a physical procedure (Intracavitary Brachytherapy) with hardware (Nucletron remote afterloading equipment, GYN Applicators). There is no mention of software as the primary or sole component.
Based on the provided information, the Smit Sleeve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Smit Sleeve Function: The description clearly states the Smit Sleeve is an accessory used during a medical procedure (Intracavitary Brachytherapy). It is physically inserted into the patient's body to aid in the delivery of radiation. It does not analyze any biological samples.
Therefore, the Smit Sleeve falls under the category of a medical device used for treatment delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.
The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and the CT/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN Applicators.
Product codes
JAQ
Device Description
The Nucletron Smit Sleeve as described in this submission is designed as an accessory to the Nucletron remote afterioading equipment and is intended for Intracavitary Brachytherapy procedures.
The Smit Sleeve has a Flange, which is sutured against the cervix. The Smit Sleeve prevents that the Intrauterine Tube of the Gynaecological Applicator is inserted to deep in the Uterus.
The Smit Sleeve is left in the patient between fractions. Between fractions the Intrauterine The of the Gynaecological Applicator can be inserted into the endometrium multiple times without dilating the Cervix. After the treatment the Smit Sleeve is removed.
The device uses similar (implantable) materials as in the legally marketed predicate device cited the Intracavitary Mould. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set.
The Smit Sleeve is used as an accessory to the Nucletron microSelectron.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "Nucletron" in bold, black font, next to a square logo. The logo contains a black circle with two white circles on opposite sides. The logo is enclosed in a black square.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O. Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section
NOV - 9 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION As required by section 807.92(c)
Submitter of 510(k):
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Smit Sleeve |
|---|---|
| Common/Usual Name: | Remote Afterloading for Intracavitary Brachytherapy applications |
| Classification Name: | Remote controlled radionuclide applicator system accessory |
| Classification: | 21Cfr892.5700 Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
a for a comments of the country of the county of the
Manufacturer | Acres State
.
Jevice | 510k
. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| NUCletron | Annlicator
1501051
Miami
100 - 10 - 100 - 100 - 100
annon and a cases of
Company of the consideration of the consideration of the contrôleants of the comments of | K953946 |
Description:
The Nucletron Smit Sleeve as described in this submission is designed as an accessory to the Nucletron remote afterioading equipment and is intended for Intracavitary Brachytherapy procedures.
The Smit Sleeve has a Flange, which is sutured against the cervix. The Smit Sleeve prevents that the Intrauterine Tube of the Gynaecological Applicator is inserted to deep in the Uterus.
1
Kojzzzž
The Smit Sleeve is left in the patient between fractions. Between fractions the Intrauterine The of the Gynaecological Applicator can be inserted into the endometrium multiple times without dilating the Cervix. After the treatment the Smit Sleeve is removed.
The device uses similar (implantable) materials as in the legally marketed predicate device cited the Intracavitary Mould. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set.
The Smit Sleeve is used as an accessory to the Nucletron microSelectron.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.
Summary of technological considerations:
The Smit Sleeve is substantially equivalent to the cleared predicate device, Miami Vaginal Applicator Set, 510(k)#: K953946.
TA
Name: Frits van Krieken Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
8th June 2005
Date
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined lines forming a shape reminiscent of a bird or wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the central emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nucletron Corporation % Elizabeth Rosenfeld Administrative Coordinator KEMA Ouality B.V./KEMA Medical 4377 Country Line Road CHALFONT PA 18914
K052228 Re.:
Trade/Device Name: Smit Sleeve Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system. Regulatory Class: II Product Code: JAQ
Dated: November 2, 2005 Received: November 3, 2005
Dear Ms. Rosenfeld:
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 (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.
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); good manufacturing practice requirements as set forth in the quality systems (OS)
NOV - 9 2005
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k)
| Number | K052228 |
|---|---|
| Device Name | Smit Sleeve |
| Indications for | |
| Use | The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving |
| Nucletron remote afterloading equipment. | |
| The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and | |
| the CT/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN | |
| Applicators. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Dana C. Beardon
(Division Sign-Off) -Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __