(49 days)
PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.
This document is a 510(k) summary for the PureSperm® Buffer, a medical device used in assisted reproduction. The information provided heavily emphasizes the substantial equivalence of the device to a predicate device rather than detailing specific performance criteria or a comprehensive study report in the way a contemporary AI/ML device submission would.
Therefore, many of the requested points regarding acceptance criteria, performance metrics, and study design are not applicable or not provided in this 2001 510(k) submission. This is typical for device submissions from this era, especially for reproductive media which are generally considered lower risk than software-as-a-medical-device.
Here is the information extracted and formatted to the best of what's available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." |
| Intended Use | "The intended use of the product is the same [as the predicate device]." |
| Composition Similarity | "Based on the similarity of composition..." |
| Product Testing Results | "...product testing results..." (Specific results not detailed in this summary.) |
Note: The submission relies on "substantial equivalence" to a predicate device (K000621, SpermRinse™) rather than setting and meeting de novo acceptance criteria. Specific quantitative performance metrics are not specified in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical trials and comparative testing," but no details are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of the device (reproductive media) and the era of the submission, formal adjudication methods like 2+1 or 3+1 are highly unlikely to have been part of the assessment for this type of product.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
- MRMC Study: No, an MRMC study was not done. This type of study is primarily relevant for imaging-based diagnostic devices where human readers are interpreting data, which is not the case for this reproductive media.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done
- Standalone Study: Not applicable. This device is a biochemical solution, not an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. The submission primarily relies on "comparative testing" against a predicate device and "clinical trials." For reproductive media, ground truth would likely be established through in-vitro biological assays (e.g., sperm viability, motility, morphology post-processing) and potentially in-vivo outcomes data (e.g., fertilization rates, pregnancy rates in clinical use), but these details are not present in this 510(k) summary.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a biochemical solution, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. This device is a biochemical solution, not an AI/ML algorithm.
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K011606
Page 1 of 2
EXHIBIT 2
NidaCon International AB
Mölndalsvägen 22 S-412 63, Göteborg, Sweden
Tel +46-31-405440 Fax +46 31-405415
Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager June 7, 2001
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: PureSperm® Buffer I Classification Name/Product Code: Reproductive Media and Supplements (21 CFR 884.6180) Procode: 85 MQL Common/Usual Name: Assisted Reproduction Media
-
- Equivalent legally marketed devices: K000621, SpermRinse TM
-
- Description of the Device: Buffer PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria.. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.
Page 8
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K011606
Page 2 of 2
-
- Safety and Effectiveness, comparison to predicate devices. The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device. The intended use of the product is the same.
-
- Conclusion: Based on the similarity of composition, product testing results, and intended use, PureSperm® Buffer is substantially equivalent to the predicate device named above.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7/10/2001
JUL 1 2 2001
NidaCon International AB c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K011606 PureSperm® Buffer Dated: May 22, 2001 Received: May 24, 2001 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Kamm:
We have reviewed your Section 510(k) notification of intent to market the device received and we have are decembers We have reviewed your Section 510(K) noticallon of the enclosure) to legally marketed precicate devices as to sevices device is substantially equivalent (or the nations to the Medical Device Americal Device American of total Art (4 ct (4 c) marketed in interstate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recalastined in accordance with and provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general on provinces, 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 (Premater Approval), it may be subjict If your device is classified (See above) nito chack of copied obtaring or abe found in the Code of Federal Regulations, to such additional controls. Existing major regulation assumes compliance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalia detect C Title ZI, Parts 800 to 893. A subsantary equration (QS) for Medical Device) Central regulation (21 CFR Partic Practice requirements, as set four in the Quality Dystems of Copinistration (FDA) will verify such assumptions. Fallure 820) and that, through periodic QS inspection. In 27 och and 27th, 1 chimston, N. May woldlish further announcements to comply with the GMT regulation in regulatory this response to your premarket notified of the most be dest concerning your device in the Federal Register. Tease noter and respected of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarker notification for use and I his letter will allow you to begally marketed predicated in your evelized and one 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 Pat 801 additionally 809.10 for invited If you desire specific advice tor your device of Compliance at (301) 594-4639. Additionally, for quest of the promotion diagnosite devices), prease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information of your entitled, "Misbranding by telefited from the Division of Small Many from the March (800)-free number (800)
responsibilities under the Act may be obtained from the Division of Tesponsibilities under the riter be obtaint address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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j) Indications for Use
510(k) Number k01166
Device Name: PureSperm® Buffer
Indications for Use: The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use /\ OR Over the Counter Use
(Per 21 CFR 801.109) _
Nancy Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K011606
Page 7
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.