(283 days)
Not Found
Not Found
No
The device description and performance studies focus on a manual biopsy instrument and its ability to collect a tissue sample, with no mention of AI or ML for analysis or interpretation.
No
The device is intended for obtaining a biopsy for diagnosis, not for treating a disease or condition.
Yes
Explanation: The device is intended for "obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis," which directly points to its role in diagnosis.
No
The device description clearly states it is a "biopsy instrument consisting of a sampling head and a handle," indicating it is a physical, manual medical device, not software.
Based on the provided information, the SpiraBrush Cx is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SpiraBrush Cx is a manual instrument used to obtain the tissue sample. It is the tool for collection, not the device that performs the diagnostic test on the sample.
- The intended use states that the tissue samples obtained by the SpiraBrush Cx should be evaluated using a histologic technique. This histologic evaluation is the diagnostic process, which is performed in a laboratory using other devices and procedures.
- The device description clearly describes a physical instrument for collecting a sample.
- The performance study focuses on the adequacy of the tissue sample obtained by the SpiraBrush Cx and its equivalence to a standard biopsy method for providing a sample suitable for histological diagnosis. It does not evaluate the diagnostic performance of the SpiraBrush Cx itself.
In summary, the SpiraBrush Cx is a biopsy instrument used to collect a tissue sample, which is then processed and diagnosed using other methods. It is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
- "SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique."
- "SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique."
Product codes (comma separated list FDA assigned to the subject device)
85 HFB-Gynecological Biopsy Forceps, 85 HHT-Cervical Spatula
Device Description
SpiraBrush Cx is a sampling tool with a sampling head and a handle, designed for obtaining cervical biopsies. It is used to collect tissue samples from visible exocervical lesions. The procedure involves placing the sampling head onto the lesion, applying pressure, and rotating the brush until a sufficient sample is obtained. After sampling, the brush head is snapped off the handle and placed into an alcohol-based cytology solution for laboratory processing. The tissue is then manually removed from the brush head for histologic evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
exocervical lesions, cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider, laboratory
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)
Clinical Trial:
Population: A population of 41 female subjects at 4 investigation sites scheduled for LEEP due to visible exocervical lesions had both a SpiraBrush Cx Biopsy and cervical punch biopsy prior to LEEP. 37 subjects (90%) completed all phases of the investigation and were able to be used for evaluation.
Conclusions: The clinical trial supported that the SpiraErush Cx Biopsy Instrument produced an adequate transepithelial cervical biopsy that was substantially equivalent to a standard cervical punch biopsy for producing a tissue specimen that a reviewing pathologists could utilize to arrive at a meaningful clinical diagnosis by accepted cervical classification systems. SpiraBrush Cx Biopsy safety and effectiveness was further supported by tissue confirmation by LEEP or conization. The SpiraBrush cervical biopsy also produced less pain and bleeding for patients then standard cervical punch biopsy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological 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 § 884.9.
0
K-011488
FEB 2 2 2002
SUMMARY OF SAFETY & EFFECTIVENESS STATEMENT VIII.
SpiraBrush Indications for Use:
SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.
Clinical Trials:
In clinical trials, the SpiraBrush CX biopsy instrument resulted in less frequent need for hemostasis as compared with the standard punch biopsy.
Procedure:
SpiraBrush Cx Biopsy Instrument is intended for obtaining a cervical biopsy of a suspicious area or visible exocervical lesion detected during vaginal examination. The patient is maintained in a standard lithotomy position during the SpiraBrush Cx Biopsy Instrument sampling.
Image /page/0/Figure/9 description: The image shows a SpiraBrush, which is a sampling tool. The SpiraBrush has two main parts: the sampling head and the handle. The sampling head is the part that is used to collect the sample, and the handle is the part that is used to hold the brush.
SpiraBrush Biopsy Procedure
- The head of the SpiraBrush® Cx Biopsy Instrument (see diagram) is placed 1. directly onto the exocervical lesion or cervical area that is to be biopsied (handle will be at 90 degree angle to the cervix). The flat surface of the SpiraBrush head tip is to remain in contact with the cervical sampling area throughout the biopsy procedure.
- Apply firm and steady pressure to keep the brush firmly placed on the cervix, and 2. Apply firm and otoad) at least three full rotations clockwise and three full rotations counter-clockwise or until micropunctate bleeding occurs and brush head is abundantly covered with a bloody-mucoid sample.
Revised 1-18-02
1
SpiraBrush Head Removal
- After completion of the SpiraBrush cervical biopsy procedure, avoiding any 1. unnecessary manipulation of the SpiraBrush's tissue sample, the SpiraBrush head is to be snapped off of the SpiraBrush handle
- To snap the SpiraBrush head from the handle, the health care provider holds the 2. handle between the fingers and the thumb, bending the handle at the scored mark (approximately 1 ¼ inches from the brush head).
- Carefully, holding on to the SpiraBrush head and biopsy, the entire SpiraBrush 3. head and biopsy is immediately dropped into a labeled bottle of alcohol-based cytology solution.
Post Biopsy Procedure Patient Follow Up
Post SpiraBrush biopsy cervical bleeding, if present, may be gently dabbed with r ost opliabrush blopsy oor roal blesains to the cervix until bleeding stops. The vaginal examination can be resumed once bleeding has been controlled.
SpiraBrush Cx Biopsy Instrument Processing (Laboratory)
Cervical Biopsy Tissue Removal from SpiraBrush head:
- After a suitable period of fixation in the alcohol-based cytology solution, the 1. Aller a callable pollou of manually removed from the cervical tissue specimen by trained tissue processing personnel.
- Protective gloves and forceps are used for removal of the head of the SpiraBrush 2. r rolouve ground forceps after the biopsy specimen has been removed from out of the SpiraBrush, the head is discarded in an appropriate receptacle.
- Cervical biopsy tissue still clinging to the head of the SpiraBrush can be 3. manually removed by any of the following suggested methods:
- a. The SpiraBrush head is held by forceps over the preservative bottle, and The Opliablaon noad is the preservative solution to remove visible tissue still agnated up and down in the procents are allowed to fall back down into the preservative solution.
- b. Forceps are used to manually pick the tissue away from the SpiraBrush head, r oropping the fragments back into the preservative solution. However, if forceps are used to handle the actual biopsy tissue, care must be taken not to crush or distort the biopsy specimen between the tips of the forceps.
- c. The SpiraBrush head can be held just above the preservative bottle with forceps, and biopsy tissue flushed off of the head back down into the foreservative solution using an additional flush of preservative solution.
- Once the cervical biopsy has been separated from the SpiraBrush head, if 4. necessary, the remaining cervical biopsy is re-suspended, in additional preservative fluid.
2
From this step on, the SpiraBrush Cx Biopsy Instrument specimen preparation proceeds per the standard practices of the processing facility's preparation of any other cervical biopsv.
SpiraBrush® Cx Biopsy Microscopic Interpretation
A cervical biopsy obtained by the SpiraBrush Cx Biopsy Instrument is intended to be microscopically classified according to currently accepted microscopic cervical biopsy classification. Such cervical biopsy classification systems include The Bethesda and modified Bethesda Systems
Clinical Trial
Population:
A population of 41 female subjects at 4 investigation sites scheduled for LEEP due to visible exocervical lesions had both a SpiraBrush Cx Biopsy and cervical punch biopsy prior to LEEP. 37 subjects (90%) completed all phases of the investigation and were able to be used for evaluation.
Conclusions:
The clinical trial supported that the SpiraErush Cx Biopsy Instrument produced an adequate transepithelial cervical biopsy that was substantially equivalent to a standard cervical punch biopsy for producing a tissue specimen that a reviewing pathologists could utilize to arrive at a meaningful clinical diagnosis by accepted cervical classification systems. SpiraBrush Cx Biopsy safety and effectiveness was further supported by tissue confirmation by LEEP or conization. The SpiraBrush cervical biopsy also produced less pain and bleeding for patients then standard cervical punch biopsy.
Contraindications:
SpiraBrush Cx is contraindicated for use in the following patients:
- Patients who are pregnant 1.
- Patients currently on anticoagulant therapy 2.
- Patients with known bleeding disorders 3.
Warnings:
- Use of SpiraBrush Cx may cause bleeding requiring application of Monsel's solution l or silver nitrate to establish hemostasis in cases where dabbing of biopsy site is not adequate.
- In the unlikely event that the brush head separates from the handle during sampling 미 (at the scored mark), remove the handle from the vagina. Then using ring forceps, retrieve the brush head from the vagina. If sampling was complete and adequate
3
(abundantly covered with bloody-mucoid material), place sample in alcohol-based preservative solution for processing. If sampling was not completed or inadequate, obtain sample using another SpiraBrush.
Adverse Events None known
4
Image /page/4/Picture/1 description: The image shows a logo with a circular border. Inside the circle, there is a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The logo appears to be a symbol or emblem, possibly representing an organization or institution.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Stewart A. Lonky, M.D. Chief Medical Officer The TRYLON Corporation 970 West 190th Street, Suite 850 TORRANCE CA 90502-1037
Re: K011488 Trade/Device Name: SpirabrushCx® Biopsy Brush Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code(s): 85 HFB-Gynecological Biopsy Forceps 85 HHT-Cervical Spatula Dated: November 21, 2001 Received: November 26, 2001
Dear Dr. Lonky:
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.
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 (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.
5
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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:
| 8xx. l xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Yarry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 1 of l
510(k) NUMBER (IF KNOWN): _K011488
DEVICE NAME: SpiraBrush Cx
INDICATIONS FOR USE:
SpiraBrush Indications for Use:
SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.
Clinical Trials
In clinical trials, the SpiraBrush CX biopsy instrument resulted in less frequent need for hemostasis as compared with the standard punch biopsy.
(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
(Optional Format 1) |
| ------------------------------------------ | --------------------------------------------------- | ---- | --------------------------------------------- |
|---|
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K011488